Data / Medical devices / Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component (KTT): 205 FDA-registered makers in 18 countries

Name: FDA-registered makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

205 establishments in 18 countries are registered with the FDA to make Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component (product code KTT, Class 2, 21 CFR 888.3030). 65 of them have a 510(k) clearance or PMA approval on file and 12 have a recall event. The FDA has issued 405 510(k) clearances under this code, the latest on October 2, 2026, and lists 51 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Product code: KTT
Device class: 2
Regulation: 888.3030
Medical specialty: Orthopedic
Implant: Yes

Makers by country

Country	Makers
United States	122
Switzerland	18
Germany	17
China	15
Taiwan	5
Malaysia	5
Italy	4
France	3
South Korea	3
India	2
Ireland	2
United Kingdom	2
Poland	2
Canada	1
Israel	1
Sweden	1
Austria	1
Costa Rica	1

Makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Biomet, Inc.	Warsaw, IN, United States	Manufacturer, Repackager or relabeler	53	December 15, 2011	4	api.fda.gov
Synthes (USA) Products LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	40	June 11, 2026	1	api.fda.gov
Synthes GMBH	Zuchwil Solothurn, Switzerland	Specification developer	35	June 11, 2026	0	api.fda.gov
STRYKER GmbH	SELZACH Solothurn, Switzerland	Complaint file establishment, Manufacturer, Specification developer	31	December 19, 2025	6	api.fda.gov
Synthes GMBH	Selzach Solothurn, Switzerland	Exporter to the US, Manufacturer	19	June 11, 2026	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	17	July 29, 2021	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	17	July 29, 2021	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	14	December 8, 2020	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Complaint file establishment, Specification developer	14	June 6, 2018	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Manufacturer	13	June 6, 2018	0	api.fda.gov
Stryker Sustainability Solutions Phoenix	Phoenix, AZ, United States	Reprocessor	11	January 13, 2016	0	api.fda.gov
Stryker Sustainability Solutions	Tempe, AZ, United States	Specification developer	10	January 13, 2016	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer	10	December 30, 2015	4	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	9	August 8, 2025	0	api.fda.gov
Orthofix SRL	BUSSOLENGO Verona, Italy	Manufacturer	8	December 3, 2024	3	api.fda.gov
Paragon 28	Englewood, CO, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	7	December 19, 2025	0	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	6	March 7, 2025	1	api.fda.gov
Sterilmed, Inc.	Plymouth, MN, United States	Reprocessor, Specification developer	5	November 10, 2016	0	api.fda.gov
Vilex LLC	Mcminnville, TN, United States	Manufacturer, Repackager or relabeler	5	April 17, 2026	0	api.fda.gov
Innomedic GmbH	Phillipsburg-Rheinsheim Baden-Wurttemberg, Germany	Specification developer	4	June 11, 2026	0	api.fda.gov
JMG Machine, Inc.	La Mirada, CA, United States	Contract manufacturer, Manufacturer	4	December 15, 2011	0	api.fda.gov
Merete GMBH	Berlin, Germany	Specification developer	4	December 3, 2010	0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	4	July 29, 2021	0	api.fda.gov
Citieffe SRL	Calderara di Reno Bologna, Italy	Manufacturer	3	March 20, 2017	0	api.fda.gov
Medshape, Inc.	Atlanta, GA, United States	Complaint file establishment, Specification developer	3	February 16, 2016	1	api.fda.gov
CREATEC GmbH & CO. KG	FRIEDRICHSHAFEN Baden-Wurttemberg, Germany	Contract manufacturer, Exporter to the US	2	September 18, 2014	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Specification developer	2	April 15, 1986	1	api.fda.gov
Fusion Orthopedics Usa, LLC	Mesa, AZ, United States	Complaint file establishment, Specification developer	2	May 30, 2024	3	api.fda.gov
Gexfix SA	Le Grand-Saconnex Geneve, Switzerland	Manufacturer	2	December 28, 2016	0	api.fda.gov
GLW, Inc.	Englewood Cliffs, NJ, United States	Complaint file establishment, Specification developer	2	September 14, 2020	0	api.fda.gov
Medicalplastic	MILANO Lombardy, Italy	Specification developer	2	September 27, 2010	1	api.fda.gov
Medline ReNewal	Redmond, OR, United States	Reprocessor	2	July 27, 2018	0	api.fda.gov
NUTEK Orthopaedics, Inc	Fort Lauderdale, FL, United States	Specification developer	2	May 15, 2013	0	api.fda.gov
Pioneer Surgical Technology, Inc.	Marquette, MI, United States	Manufacturer	2	December 30, 2015	0	api.fda.gov
Response Ortho Solutions LLC	Boynton Beach, FL, United States	Manufacturer	2	November 20, 2025	0	api.fda.gov
The Orthopaedic Implant Company	Reno, NV, United States	Specification developer	2	September 27, 2017	0	api.fda.gov
Aap Implantate AG	Berlin, Germany	Manufacturer	1	August 29, 2007	0	api.fda.gov
Acumed LLC	Hillsboro, OR, United States	Manufacturer	1	September 17, 2010	0	api.fda.gov
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Manufacturer	1	December 21, 2010	0	api.fda.gov
Aike (shanghai) Medical Instrument Co., Ltd.	Shanghai, China	Manufacturer	1	January 5, 2021	0	api.fda.gov
Auxein medical Private limited	Sonipat Haryana, India	Complaint file establishment, Manufacturer	1	November 30, 2023	0	api.fda.gov
Biomet France	Valence Drome, France	Manufacturer	1	October 9, 1997	0	api.fda.gov
BK Meditech Co., Ltd.	Hwaseong-si Gyeonggi, South Korea	Manufacturer	1	November 2, 2011	0	api.fda.gov
Blueocean Global Corp	Southold, NY, United States	Specification developer	1	January 20, 2026	0	api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, China	Contract manufacturer, Manufacturer	1	October 9, 1997	0	api.fda.gov
Extremity Medical, LLC	Parsippany, NJ, United States	Complaint file establishment, Repackager or relabeler, Specification developer	1	May 7, 2025	0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	1	January 12, 2018	0	api.fda.gov
Jeil Medical Corporation	Siheung-si Gyeonggi, South Korea	Manufacturer	1	September 28, 2015	0	api.fda.gov
Jeil Medical Corporation	Seoul, South Korea	Manufacturer	1	September 28, 2015	0	api.fda.gov
Kaul Medizintechnik GMBH	Dierdorf Rhineland-Palatinate, Germany	Complaint file establishment, Foreign private label distributor, Specification developer	1	November 30, 2023	0	api.fda.gov
Kinamed, Inc.	Camarillo, CA, United States	Manufacturer	1	November 9, 2007	1	api.fda.gov
Kyocera Medical Technologies, Inc.	Redlands, CA, United States	Complaint file establishment, Specification developer	1	May 11, 2011	0	api.fda.gov
Life Spine	Huntley, IL, United States	Specification developer	1	September 7, 2018	0	api.fda.gov
Medusa Orthopedics, LLC	Fleetwood, PA, United States	Manufacturer	1	November 25, 2025	0	api.fda.gov
Metric Medical Devices, Inc.	Helotes, TX, United States	Manufacturer	1	May 29, 2024	0	api.fda.gov
Nuvasive, Inc.	Guaynabo, PR, United States	Manufacturer	1	November 7, 2019	0	api.fda.gov
NuVasive Specialized Orthopedics, Inc.	Audubon, PA, United States	Manufacturer	1	November 7, 2019	0	api.fda.gov
Orthonovis, Inc.	Palm Coast, FL, United States	Manufacturer, Specification developer	1	August 25, 2022	0	api.fda.gov
Orthopediatrics Canada ULC	Laval Quebec, Canada	Manufacturer	1	September 8, 2017	0	api.fda.gov
Sequel Medical Inc.	Fort Lauderdale, FL, United States	Specification developer	1	January 19, 2021	0	api.fda.gov
SIGN Fracture Care International	Richland, WA, United States	Manufacturer	1	August 26, 2009	0	api.fda.gov
Stryker Ireland Osteonics	County Cork, Ireland	Manufacturer	1	August 17, 1987	0	api.fda.gov
Stryker Leibinger GMBH & Co. KG	FREIBURG Baden-Wurttemberg, Germany	Contract manufacturer, Manufacturer	1	August 5, 2005	0	api.fda.gov
Zimmer Manufacturing B.V.	Mercedita, PR, United States	Manufacturer	1	May 1, 2015	2	api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, China	Manufacturer	1	October 9, 1997	0	api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)	Riviera Beach, FL, United States	Contract manufacturer	0		0	api.fda.gov
Advanced Concept Innovations LLC	Lakeland, FL, United States	Contract manufacturer	0		0	api.fda.gov
Alden Tool Company, Inc.	Berlin, CT, United States	Contract manufacturer	0		0	api.fda.gov
Anthogyr	SALLANCHES Haute-Savoie, France	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Elmhurst	Elmhurst, IL, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Warsaw	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Armbruster GMBH	Steinach Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Automatics Tooling Company Ltd	Salfords Surrey, United Kingdom	Contract manufacturer	0		0	api.fda.gov
Apex (Guangzhou) Tools & Orthopedics Company	Guangzhou Guangdong, China	Contract manufacturer	0		0	api.fda.gov
Aristotech Industries GmbH	Berlin, Germany	Contract manufacturer	0		0	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Autocam Medical	Murfreesboro, TN, United States	Contract manufacturer	0		0	api.fda.gov
Avalign Delivery Systems Division	Greenwood, IN, United States	Contract manufacturer	0		0	api.fda.gov
B & G MFG. Co.	Hatfield, PA, United States	Contract manufacturer	0		0	api.fda.gov
B & J Medical LLC	Kendallville, IN, United States	Contract manufacturer	0		0	api.fda.gov
Banister Tool, Inc.	Pflugerville, TX, United States	Contract manufacturer	0		0	api.fda.gov
BHH Mikromed	Dabrowa Gornicza Slaskie, Poland	Contract manufacturer	0		0	api.fda.gov
Branch Medical Group	Eagleville, PA, United States	Contract manufacturer	0		0	api.fda.gov
Branch Medical Group	Limerick, PA, United States	Contract manufacturer	0		0	api.fda.gov
BioDynamik	Lake Forest, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Canwell Medical Co., Ltd.	Jinhua Zhejiang, China	Contract manufacturer	0		0	api.fda.gov
Composites Busch SA	Porrentruy Jura, Switzerland	Contract manufacturer	0		0	api.fda.gov
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0		0	api.fda.gov
CarboFix Orthopedics, Ltd.	Herzeliya Central, Israel	Manufacturer	0		0	api.fda.gov
Complexus Medical	Mishawaka, IN, United States	Contract manufacturer	0		0	api.fda.gov
Criterion Tool & Die Inc DBA Criterion Precision Machining	Brookpark, OH, United States	Contract manufacturer	0		0	api.fda.gov
Dot GMBH	Rostock Mecklenburg-Western Pomerania, Germany	Contract manufacturer	0		0	api.fda.gov
Elos Medtech Timmersdala AB	TIMMERSDALA Vastra Gotaland, Sweden	Contract manufacturer	0		0	api.fda.gov
Eptam West LLC	Colorado Springs, CO, United States	Contract manufacturer	0		0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Five Star Manufacturing, Inc.	New Bedford, MA, United States	Contract manufacturer	0		0	api.fda.gov
Frueh Verpackungstechnik AG	Fehraltorf Zurich, Switzerland	Contract manufacturer	0		0	api.fda.gov
Gauthier Biomedical, Inc.	Grafton, WI, United States	Contract manufacturer	0		0	api.fda.gov
General Machine, Inc.	Colorado Springs, CO, United States	Contract manufacturer	0		0	api.fda.gov
GPC Medical Limited	Ghaziabad Uttar Pradesh, India	Manufacturer	0		0	api.fda.gov
Guardian Medical Usa, Inc	Swanton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Hangzhou Sino-Mim Technology Co., Ltd.	Hangzhou Zhejiang, China	Contract manufacturer	0		0	api.fda.gov
Harwood Design, Inc.	Bristol, PA, United States	Contract manufacturer	0		0	api.fda.gov
HG Medical GmbH	Raisting Bavaria, Germany	Contract manufacturer	0		0	api.fda.gov
HN And M GMBH	Derendingen Solothurn, Switzerland	Contract manufacturer	0		0	api.fda.gov
Huron Tool & Cutter Grinding	Farmingdale, NY, United States	Contract manufacturer	0		0	api.fda.gov
Hipp Medical AG	Renquishausen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
I.T.S. GMBH	LASSNITZHOEHE Steiermark, Austria	Manufacturer	0		0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Intai Technology Corp. Implants Business Unit	Taichung City, Taiwan	Manufacturer	0		0	api.fda.gov
Intrauma	Bruino Torino, Italy	Manufacturer	0		0	api.fda.gov
J&B Precision, Inc.	Cordova, TN, United States	Contract manufacturer	0		0	api.fda.gov
Jatex, Inc.	Nappanee, IN, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Inc. (Brandywine)	W Chester, PA, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Inc. (Elmira)	Horseheads, NY, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Switzerland Manufacturing GmbH (Balsthal)	Balsthal Solothurn, Switzerland	Contract manufacturer	0		0	api.fda.gov
Jabil Switzerland Manufacturing GmbH (Bettlach)	Bettlach Solothurn, Switzerland	Contract manufacturer	0		0	api.fda.gov
Jabil Switzerland Manufacturing GmbH (Grenchen)	Grenchen Solothurn, Switzerland	Contract manufacturer	0		0	api.fda.gov
Jabil Switzerland Manufacturing GmbH (Hagendorf)	Hagendorf Solothurn, Switzerland	Contract manufacturer	0		0	api.fda.gov
Jabil Switzerland Manufacturing GmbH (Mezzovico)	Mezzovico Ticino, Switzerland	Contract manufacturer	0		0	api.fda.gov
Jabil Switzerland Manufacturing GmbH (Raron)	Raron Valais, Switzerland	Contract manufacturer	0		0	api.fda.gov
Jabil Tuttlingen Manufacturing GmbH	Tuttlingen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Kammerer Medical Systems GmbH & Co. KG	Stockach Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
LX Precision Shanghai Co Ltd	Shanghai, China	Contract manufacturer	0		0	api.fda.gov
Mackay Manufacturing, Inc.	Spokane Valley, WA, United States	Contract manufacturer	0		0	api.fda.gov
Mahe Medical Usa	Laramie, WY, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Contract manufacturer	0		0	api.fda.gov
Matrix Machining Technologies, Inc.	Memphis, TN, United States	Contract manufacturer	0		0	api.fda.gov
Mawatec AG	Selzach Solothurn, Switzerland	Contract manufacturer	0		0	api.fda.gov
Medartis AG	BASEL Basel-Stadt, Switzerland	Manufacturer	0		0	api.fda.gov
Medcare Solutions GMBH	Emmingen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Medical Device And Implants LLC	Lancaster, PA, United States	Contract manufacturer	0		0	api.fda.gov
Micro Precision Swiss	Santa Ana, CA, United States	Contract manufacturer	0		0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Microware Precision Co., Ltd.	Taichung, Taiwan	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	api.fda.gov
MK medical GmbH	Emmingen-Liptingen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Moser-Baer AG	Sumiswald Bern, Switzerland	Contract manufacturer	0		0	api.fda.gov
Mount MFG	Marquette, MI, United States	Contract manufacturer	0		0	api.fda.gov
Machining Midtown LLC	Atlanta, GA, United States	Contract manufacturer	0		0	api.fda.gov
Maestro Logistics, LLC	Austin, TX, United States	Contract manufacturer	0		0	api.fda.gov
Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, Costa Rica	Manufacturer	0		0	api.fda.gov
New Deantronics Taiwan Ltd.	New Taipei City, Taiwan	Contract manufacturer	0		0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
New Paradigm Biomedical, LLC	Dorchester, MA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Nypro Inc (Maple Grove)	Maple Grove, MN, United States	Contract manufacturer	0		0	api.fda.gov
Odyssey Medical Technologies, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	Contract manufacturer	0		0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0		0	api.fda.gov
Ortho Solutions Sdn Bhd	Prai, Penang Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Ortho Solutions UK Limited	Maldon Essex, United Kingdom	Manufacturer	0		0	api.fda.gov
OsteoCentric Technologies,Inc	Logan, UT, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Paonan Biotech Co., Ltd	Taipei, Taiwan	Manufacturer	0		0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0		0	api.fda.gov
Precision Forms, Inc.	Butler, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Precision Medical Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Precision Medical Technologies	Rome City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Precision One Medical	Oceanside, CA, United States	Contract manufacturer	0		0	api.fda.gov
Pro-Tech Design & MFG., Inc.	Santa Fe Springs, CA, United States	Contract manufacturer	0		0	api.fda.gov
Pulse Technologies, Inc.	Quakertown, PA, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Paragon Medical Inc.	Castleton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0		0	api.fda.gov
Precision One Medical	Hoover, AL, United States	Contract manufacturer	0		0	api.fda.gov
Qualitex Ne LLC	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Quintus, Inc.	Camp Verde, AZ, United States	Contract manufacturer	0		0	api.fda.gov
Rayco Steel Process, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
RMS Co.	Minneapolis, MN, United States	Contract manufacturer	0		0	api.fda.gov
SCT, Inc.	Franklin Lakes, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Smith & Nephew Orthopaedics AG	AARAU Aargau, Switzerland	Manufacturer	0		0	api.fda.gov
SMT Schilling Metalltechnik GMBH	MUHLHEIM Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Spitrex Orthopedics Switzerland SA	Le Locle Neuchatel, Switzerland	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Simpang Ampat Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Perai Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Bandar Cassia Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Structure Medical, LLC.	Naples, FL, United States	Contract manufacturer	0		0	api.fda.gov
Suzhou And Science & Technology Development Corp.	Zhangjiagang Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Polyvac SAS	WAMBRECHIES Nord, France	Contract manufacturer	0		0	api.fda.gov
Syntec Scientific Corp.	CHANG HUA Changhua, Taiwan	Contract manufacturer	0		0	api.fda.gov
Smith and Nephew Operations Sdn. Bhd	Penang Pulau Pinang, Malaysia	Manufacturer	0		0	api.fda.gov
Structure Medical, LLC.	Mooresville, NC, United States	Contract manufacturer	0		0	api.fda.gov
Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd.	Changzhou, Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Stryker Poland Manufacturing Sp. z o.o.	Skawina Malopolskie, Poland	Contract manufacturer	0		0	api.fda.gov
Suzhou Ahno Medical Devices Co., Ltd.	Suzhou Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
TORNIER Inc.	Columbia City, IN, United States	Specification developer	0		0	api.fda.gov
Tornier, Inc.	Bloomington, MN, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Triangle Manufacturing Co., Inc.	Upper Saddle River, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Turnxon Precision Co., Ltd	Dongguan Guangdong, China	Contract manufacturer	0		0	api.fda.gov
Tegra Medical	Hernando, MS, United States	Contract manufacturer	0		0	api.fda.gov
Trilliant Surgical LLC	Houston, TX, United States	Contract manufacturer	0		0	api.fda.gov
Victoria Precision Inc.	Trevose, PA, United States	Contract manufacturer	0		0	api.fda.gov
Viant Medical, LLC	Fort Wayne, IN, United States	Contract manufacturer, Manufacturer for export	0		0	api.fda.gov
X-Bolt Orthopedics	Santry Dublin(County), Ireland	Manufacturer	0		0	api.fda.gov
Yu Xin Technology(huizhou) Co.,ltd	HuiZhou Guangdong, China	Contract manufacturer	0		0	api.fda.gov
Zibo Dante Co, Ltd	Zibo City Shandong, China	Contract manufacturer	0		0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	0		0	api.fda.gov

Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.