Name: FDA 510(k) Medical Device Manufacturers
Creator: 510k Database

FDA 510(k) Orthopedic Device Manufacturers

Medical device manufacturers active in the FDA Orthopedic review panel, ranked by 510(k) submission volume. Real data from the 510k Database dataset.

Compare manufacturers by FDA 510(k) submission activity

Identify clearance rates, active panels and years of FDA activity

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Orthopedic Manufacturers

1–50 of 757

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Arthrex, Inc. Naples	111	100%	OR SU	US
2	Medacta International S.A. Castel San Pietro	99	100%	OR RA SU	CH
3	Boston Scientific Corporation Marlborough	93	99%	AN CV EN +6	US
4	Smith & Nephew, Inc. Mchenry	63	100%	OR SU	US
5	Medtronic, Inc. Mounds View	54	100%	CV NE OR +2	US
6	Depuy Ireland UC Ringaskiddy	46	100%	OR RA	IE
7	Alphatec Spine, Inc. Carlsbad	43	100%	NE OR RA	US
8	Globus Medical, Inc. Audubon	41	100%	NE OR RA +1	US
9	Paragon 28, Inc. Englewood	41	100%	OR	US
10	Brainlab AG Heimstetten	41	100%	EN NE OR +1	DE
11	SeaSpine Orthopedics Corporation Carlsbad	40	100%	OR	US
12	Medline Industries, Inc. Mchenry	35	97%	AN GU HO +4	US
13	Medtronic Sofamor Danek USA, Inc. Memphis	34	100%	OR SU	US
14	Baxter Healthcare Corporation Round Lake	34	97%	CV GU HO +1	US
15	Zimmer, Inc. Warsaw	33	100%	OR	US
16	Medos International SARL Raynham	33	100%	NE OR SU	US
17	Life Spine, Inc. Hoffman Estates	32	100%	OR	US
18	Medline Industries, LP Nortfield	29	100%	AN CV HO +3	US
19	Stryker GmbH Selzach, Solothurn, Ch	29	100%	OR	CH
20	Signature Orthopaedics Pty, Ltd. Lane Cove	26	100%	OR	AU
21	Lima Corporate S.P.A. Winona Lake	26	100%	OR	US
22	Howmedica Osteonics Corp., Dba Stryker Orthopaedics Malwah	25	100%	OR	US
23	Nu Vasive, Incorporated San Diego	25	100%	OR	US
24	Stryker Portage	24	100%	DE NE OR +1	US
25	L & K Biomed Co., Ltd. Yongin-Si	22	100%	OR	KR
26	Conmed Corporation Utica	22	100%	HO NE OB +2	US
27	Nvision Biomedical Technologies, Inc. San Antonio	22	100%	NE OR	US
28	Stryker Endoscopy San Jose	21	100%	OB OR SU	US
29	TriMed, Inc. Saugus	21	100%	OR	US
30	Vy Spine, LLC Tallahassee	21	100%	OR	US
31	Orthocon, Inc. Stamford	20	100%	NE OR SU	US
32	Waldemar Link GmbH & Co. KG Mchenry	20	100%	OR	US
33	SurGenTec, LLC Boca Raton	20	100%	OR SU	US
34	Skeletal Dynamics, Inc. Miami	20	100%	OR	US
35	Carlsmed, Inc. La Jolla	20	100%	OR RA	US
36	KLS-Martin L.P. Jacksonville	19	100%	DE NE OR	US
37	OSSIO , Ltd. Caesarea	19	100%	OR	IL
38	Jeil Medical Corporation Deer Field	19	100%	DE OR	US
39	Conformis, Inc. Foster City	19	100%	OR	US
40	Materialise NV Leuven	18	100%	DE NE OR +1	BE
41	Boston Scientific San Jose	18	100%	CV GU OR +1	US
42	Zavation Medical Products, LLC Flowood	18	100%	OR	US
43	Stryker Instruments Kalamazoo	17	100%	CV HO NE +3	US
44	OrthoPediatrics Corp. Warsaw	17	100%	OR	US
45	Stryker Corporation Malwah	17	100%	EN HO NE +2	US
46	Tyber Medical, LLC Morristown	17	100%	OR	US
47	Vilex, LLC Mcminnville	17	100%	OR	US
48	Exactech, Inc. Gainesville	16	100%	OR	US
49	Encore Medical, L.P. Austin	16	100%	OR	US
50	CarboFix Orthopedics , Ltd. Herzliya	16	100%	OR	IL

About This FDA 510(k) Manufacturer Database

Data Source and Methodology

Rankings are based on the total number of published FDA 510(k) submissions per manufacturer in the 510k Database dataset, derived from FDA 510(k) public files. This is not a curated or paid listing - manufacturer rankings reflect real regulatory activity.

Used by regulatory affairs teams and medtech consultants to benchmark manufacturer activity, identify predicate device candidates, and analyze competitive positioning across FDA review panels.