Data / Medical devices / Reamer / United States

FDA-registered makers of Reamer in the United States: 156 establishments

Name: FDA-registered makers of Reamer in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

156 establishments in the United States are registered with the FDA to make Reamer (product code HTO). 2 have a 510(k) clearance or PMA approval on file and 11 have a recall event. FDA data exported November 2, 2026.

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Device: Reamer
Product code: HTO
Country: United States

Makers of Reamer in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Synthes (USA) Products LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	4	August 10, 2011	8	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	1	February 8, 1977	1	api.fda.gov
Accufix Surgical, Inc.	Laramie, WY, United States	Specification developer	0		0	api.fda.gov
Aegis Meditec, Inc.	Costa Mesa, CA, United States	Specification developer	0		0	api.fda.gov
Alden Tool Company, Inc.	Berlin, CT, United States	Contract manufacturer	0		0	api.fda.gov
Alphatec Spine, Inc.	Carlsbad, CA, United States	Manufacturer	0		0	api.fda.gov
Alva Prototypes Inc	Pottstown, PA, United States	Contract manufacturer, Remanufacturer	0		0	api.fda.gov
Aptis Medical, LLC.	Glenview, KY, United States	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 - Seabrook	Seabrook, NH, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Warsaw	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	0		1	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Autocam Medical	Kentwood, MI, United States	Contract manufacturer	0		0	api.fda.gov
AVALIGN TECHNOLOGIES, Inc.	Fort Wayne, IN, United States	Specification developer	0		0	api.fda.gov
Alphatec Spine, Inc.	Memphis, TN, United States	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 Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
B & J Medical LLC	Kendallville, IN, United States	Contract manufacturer	0		0	api.fda.gov
B-One Ortho, Corp.	Cedar Knolls, NJ, United States	Manufacturer	0		0	api.fda.gov
Banister Tool, Inc.	Pflugerville, TX, United States	Contract manufacturer	0		0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer, Repackager or relabeler, Specification developer	0		4	api.fda.gov
Biopro, Inc.	Port Huron, MI, United States	Manufacturer	0		0	api.fda.gov
Bradshaw Medical Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
C & J Industries, Inc.	Meadville, PA, United States	Contract manufacturer	0		0	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0		0	api.fda.gov
Cayenne Medical, Inc.	Scottsdale, AZ, United States	Manufacturer	0		1	api.fda.gov
Centex Machining, Inc.	Round Rock, TX, United States	Contract manufacturer	0		0	api.fda.gov
Crossroads Extremity Systems LLC	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Culver Tool & Engineering	Plymouth, 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
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer	0		0	api.fda.gov
Depuy Spine, Inc.	Raynham, MA, United States	Specification developer	0		0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	api.fda.gov
DT Medtech LLC	McMinnville, TN, United States	Specification developer	0		0	api.fda.gov
DePuy Mitek, Inc.	Raynham, MA, United States	Specification developer	0		1	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	0		1	api.fda.gov
Eptam West LLC	Colorado Springs, CO, United States	Contract manufacturer	0		0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	0		0	api.fda.gov
Elite Medical, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Elite Medical, LLC	Florence, AL, United States	Contract manufacturer	0		0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Extremity Medical, LLC	Parsippany, NJ, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		1	api.fda.gov
Flex Technology Inc.	Charlottesville, VA, United States	Specification developer	0		0	api.fda.gov
FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower	Horsham, PA, United States	Specification developer	0		0	api.fda.gov
Footscientific, Inc.	Draper, UT, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Fusion Orthopedics Usa, LLC	Mesa, AZ, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	0		0	api.fda.gov
Grace Manufacturing Inc	Russellville, AR, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Gramercy Extremity Orthopedics, LLC.	Richardson, TX, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Holmed LLC	Attleboro, MA, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Manufacturer, Specification developer	0		3	api.fda.gov
Huron Tool & Cutter Grinding	Farmingdale, NY, United States	Contract manufacturer	0		0	api.fda.gov
Highridge Medical, LLC	Westminster, CO, United States	Specification developer	0		0	api.fda.gov
Incipio Devices	Huntington, IN, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Innomed, Inc.	Savannah, GA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Instrumental Machine & Development, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Intelivation Technologies, LLC	Plymouth Meeting, PA, United States	Complaint file establishment, Manufacturer, Specification developer	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
Kapp Surgical, Inc.	Cleveland, OH, United States	Manufacturer	0		0	api.fda.gov
Lenkbar LLC	Naples, FL, United States	Contract manufacturer	0		0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
Life Science Outsourcing, Inc.	Brea, CA, United States	Contract manufacturer	0		0	api.fda.gov
LaVezzi Precision, Inc	Bloomingdale, IL, United States	Contract manufacturer	0		0	api.fda.gov
LinkBio Corp.	Dover, NJ, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Linvatec Corporation	Largo, FL, United States	Manufacturer	0		0	api.fda.gov
Mahe Medical Usa	Laramie, WY, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Maxx Orthopedics Inc.	Norristown, PA, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Medical Component Specialists	Bellingham, MA, United States	Contract manufacturer	0		0	api.fda.gov
MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Medtech LLC	Millington, TN, United States	Contract manufacturer	0		0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Specification developer	0		0	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	api.fda.gov
Medline ReNewal	Redmond, OR, United States	Reprocessor	0		0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Nuell, Inc.	Leesburg, IN, United States	Contract manufacturer	0		0	api.fda.gov
NuVasive Specialized Orthopedics, Inc.	Audubon, PA, United States	Manufacturer	0		0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	api.fda.gov
Ortho Development Corp.	Draper, UT, United States	Manufacturer	0		0	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Specification developer	0		0	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Osseus Fusion Systems LLC	Dallas, TX, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Osteomed	Addison, TX, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Olive Branch Distribution Center	Olive Branch, MS, 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
Orthopedic Designs North America, Inc.	Tampa, FL, United States	Manufacturer	0		0	api.fda.gov
Pacific Instruments Inc.	Honolulu, HI, United States	Manufacturer	0		0	api.fda.gov
Packaging Compliance Medical, LLC	Kentwood, MI, United States	Contract manufacturer	0		0	api.fda.gov
Paragon 28	Englewood, CO, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Phoenix Instruments, Inc.	Lisle, IL, 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
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0		0	api.fda.gov
Phillips Precision Inc	Elmwood Park, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Precision Edge Surgical Products Co LLC	Boyne City, MI, United States	Contract manufacturer	0		0	api.fda.gov
Precision Edge Surgical Products, LLC	Angola, IN, United States	Contract manufacturer	0		0	api.fda.gov
Precision Medical Technologies- North Manchester Manufacturing Facility	N Manchester, IN, United States	Contract manufacturer	0		0	api.fda.gov
ProMed Concepts, LLC	Brighton, TN, United States	Contract manufacturer	0		0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	api.fda.gov
Rayco Steel Process, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Renovo, Inc.	Bend, OR, United States	Reprocessor	0		0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0		0	api.fda.gov
RTI Surgical, Inc. (dba RTI Biologics, Inc.)	Alachua, FL, United States	Specification developer	0		0	api.fda.gov
Ranfac Corp.	Avon, MA, United States	Manufacturer	0		0	api.fda.gov
SCT, Inc.	Franklin Lakes, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Manufacturer	0		0	api.fda.gov
SIGN Fracture Care International	Richland, WA, United States	Manufacturer	0		0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	0		0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Spine Wave, Inc.	Shelton, CT, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Sterramed Inc	Weehawken, NJ, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Suretek Medical	Greenville, SC, United States	Reprocessor	0		0	api.fda.gov
Surgical Instrument Manufacturers, LLC	Fenton, MO, United States	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
T & L Sharpening, Inc.	Indiana Beach, IN, United States	Contract manufacturer	0		0	api.fda.gov
Tecomet, Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Theken Companies, LLC	Akron, OH, United States	Specification developer	0		0	api.fda.gov
Topmed Medical Devices Inc	Irvine, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Total Joint Orthopedics, Inc.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Trigon America LLC	Aurora, IL, United States	Contract manufacturer	0		0	api.fda.gov
Trimed, Inc.	Santa Clarita, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Troy Innovative Instruments Co LLC	Middlefield, OH, United States	Contract manufacturer	0		0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	Contract manufacturer	0		0	api.fda.gov
TriPoint Surgical	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Trilliant Surgical LLC	Houston, TX, United States	Complaint file establishment, Specification developer	0		1	api.fda.gov
Tyber Medical	Bethlehem, PA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Tyber Medical	Bethlehem, PA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Unity Tool, Inc.	Osseo, MN, United States	Contract manufacturer	0		0	api.fda.gov
UOC USA Inc.	Irvine, CA, United States	Manufacturer, Manufacturer for export	0		0	api.fda.gov
Viant AS&O Holdings, LLC	Laconia, NH, United States	Contract manufacturer	0		0	api.fda.gov
Viant Medical, LLC	Fort Wayne, IN, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0		0	api.fda.gov
Vilex LLC	Mcminnville, TN, United States	Manufacturer	0		0	api.fda.gov
Warsaw Orthopedic, Inc.	Warsaw, IN, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Manufacturer	0		0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Specification developer	0		0	api.fda.gov
Xenix Medical	Orlando, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer, Repackager or relabeler	0		1	api.fda.gov
Zentech Inc.	Clearwater, FL, United States	Specification developer	0		0	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Manufacturer	0		0	api.fda.gov
b-ONE Ortho Corp.	Fairfield, NJ, United States	Specification developer	0		0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	0		0	api.fda.gov

Updated November 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.