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Data / Medical devices / Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment (KIJ): 69 FDA-registered makers in 12 countries

69 establishments in 12 countries are registered with the FDA to make Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment (product code KIJ, Class 1, 21 CFR 878.4820). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 29 510(k) clearances under this code, the latest on December 27, 2016, and lists 1 recall event (0 Class I). FDA data exported November 3, 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
KIJ
Device class
1
Regulation
878.4820
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States34
China11
South Korea6
Switzerland4
Malaysia4
India2
Ireland2
Germany2
Lithuania1
Brazil1
Mexico1
United Kingdom1

Makers of Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Jeil Medical CorporationSeoul, South KoreaManufacturer2December 27, 2016000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer2May 7, 1982000api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer1May 7, 1996000api.fda.gov
OsteomedAddison, TX, United StatesComplaint file establishment, Manufacturer, Specification developer1November 7, 1994000api.fda.gov
R & D Batteries, Inc.Burnsville, MN, United StatesManufacturer1April 5, 1994000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer1May 7, 1982000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer1May 7, 1982000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1September 4, 1997000api.fda.gov
AB Ortopedijos TechnikaKaunas Kauno Apskritis, LithuaniaManufacturer0000api.fda.gov
Apothecaries Sundries MFG Pvt LtdGURUGRAM Haryana, IndiaManufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Ari Medical Technology Co., Ltd.Hefei Anhui, ChinaManufacturer0000api.fda.gov
Apex (Guangzhou) Tools & Orthopedics CompanyGuangzhou Guangdong, ChinaContract manufacturer0000api.fda.gov
B & J Medical LLCKendallville, IN, United StatesContract manufacturer0000api.fda.gov
BioDynamikLake Forest, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Corentec Co., Ltd.Cheonan Si, Chungnam, South KoreaExporter to the US, Manufacturer0000api.fda.gov
Denjoy Dental Co., LtdChangsha city Hunan, ChinaManufacturer0000api.fda.gov
Depuy (ireland)CO. CORK Munster, IrelandSpecification developer0000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesSpecification developer0000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Depuy Ireland UCCo. Cork Munster, IrelandSpecification developer0000api.fda.gov
DynaMedic Co., Ltd.Cheongju-si Chungbuk, South KoreaManufacturer0000api.fda.gov
Gavin Biotechnology Co.,ltdJinzhong Shanxi, ChinaExporter to the US, Manufacturer0000api.fda.gov
GM Dos Reis Industria E Comercio LtdaCampinas Sao Paulo, BrazilManufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Imedicom Co., Ltd.Gunpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Insurgical, Inc.Austin, TX, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Jiangsu Saikang Medical Equipment Co., LtdZhangjiagang Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiangsu Yongfa Medical Equipment Technology Co., LtdZhangjiagang City Jiangsu, ChinaManufacturer0000api.fda.gov
Jabil Circuit de Chihuahua, S. De R.L. de C.V.Chihuahua, MexicoContract manufacturer0000api.fda.gov
KLS Martin SE & Co. KGMuhlheim/Donau Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
LaVezzi Precision, IncBloomingdale, IL, United StatesContract manufacturer0000api.fda.gov
Mainstream Medical DevicesAustin, TX, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Microaire Surgical Instruments LLCCharlottesville, VA, United StatesManufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Moser-Baer AGSumiswald Bern, SwitzerlandContract manufacturer0000api.fda.gov
MPS Micro Precision Systems AGBiel-Bienne Bern, SwitzerlandContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Norwood Medical LLCDayton, OH, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orthopediatrics, CorpWarsaw, IN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Osteonic Co., Ltd.Seoul, South KoreaExporter to the US, Manufacturer0000api.fda.gov
Ortho Solutions UK LimitedMaldon Essex, United KingdomComplaint file establishment, Specification developer0000api.fda.gov
Packaging Compliance Medical, LLCKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Peleton SurgicalScottsdale, AZ, United StatesSpecification developer0000api.fda.gov
Precision Medical TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Device (Changzhou) Co., Ltd.Changzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Paragon Medical Inc.Castleton, IN, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
Saeshin Precision Co., Ltd.Daegu, South KoreaManufacturer0000api.fda.gov
Samaplast AGSankt Margrethen Sankt Gallen, SwitzerlandContract manufacturer0000api.fda.gov
Shaanxi Ansen Medical Technology Development Co.,ltd.Xi'an Shaanxi, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shalby Advanced Technologies, Inc.El Dorado Hills, CA, United StatesManufacturer0000api.fda.gov
Shanghai No. 2 Medical College Duhang Medical Equipment FactoryShanghai, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Sigma Surgical Private LimitedAHMEDABAD Gujarat, IndiaManufacturer0000api.fda.gov
Silony Medical GMBHLeinfelden-Echterdingen Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Spineology Inc.Saint Paul, MN, United StatesManufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdSimpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdPerai Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Stryker Manufacturing KalamazooPortage, MI, United StatesContract manufacturer0000api.fda.gov
Supercomal Medical Products, Sdn BhdSUNGAI PETANI Kedah, MalaysiaContract manufacturer0000api.fda.gov
Suzhou Number Win Medical Technology Co., Ltd.Zhangjiagang Jiangsu, ChinaManufacturer0000api.fda.gov
Universal Punch Corp.Santa Ana, CA, United StatesContract manufacturer0000api.fda.gov
VorzeigenConnersville, IN, United StatesContract manufacturer0000api.fda.gov
Zurimed Technologies AGZurich, SwitzerlandComplaint file establishment, Manufacturer0000api.fda.gov

Updated December 27, 2016. 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.