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.

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Identify clearance rates, active panels and years of FDA activity

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FDA 510(k) Orthopedic Manufacturers

1–50 of 1,014

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	C.R. Bard, Inc. Covington	645	99%	AN CV EN +9	US
2	Smith & Nephew, Inc. Mchenry	530	98%	CV DE EN +9	US
3	Baxter Healthcare Corp Mchenry	505	100%	AN CH CV +14	US
4	Medtronic Vascular Walker	475	97%	AN CH CV +9	US
5	Biomet, Inc. Mchenry	441	95%	CV DE EN +9	US
6	Boston Scientific Corp San Jose	432	100%	CV EN GU +8	US
7	Synthes (Usa) Mchenry	411	96%	DE HO NE +3	US
8	Zimmer, Inc. Warsaw	376	95%	AN EN HO +6	US
9	Howmedica Corp. Mchenry	373	87%	CV DE EN +7	US
10	KARL STORZ Endoscopy-America, Inc. Mchenry	362	100%	AN CV DE +9	US
11	Arthrex, Inc. Naples	350	99%	HO OR SU	US
12	Boehringer Mannheim Corp. Mchenry	340	100%	AN CH HE +6	US
13	3M Company White City	331	98%	AN CH CV +12	US
14	Depuy, Inc. Mchenry	303	79%	CV DE GU +6	US
15	Wrightmedicaltechnologyinc Arlington	302	96%	EN HO OR +1	US
16	Howmedica Osteonics Corp. Allendale	288	100%	NE OR SU	US
17	Dentsply Intl. Walker	279	100%	AN DE HO +4	US
18	Medline Industries, Inc. Mchenry	238	100%	AN CH CV +9	US
19	Boston Scientific Corporation Marlborough	232	100%	AN CV EN +7	US
20	United States Surgical, A Division of Tyco Healthc Mchenry	218	92%	CV EN GU +6	US
21	Medtronic, Inc. Mounds View	210	100%	AN CV EN +7	US
22	Aesculap, Inc. Burlingame	207	97%	CV DE GU +5	US
23	DePuy Orthopaedics, Inc. Warsaw	207	99%	NE OR RA +1	US
24	Johnson & Johnson Professionals, Inc. Raynham	206	89%	CH CV DE +9	US
25	Ethicon, Inc. Raritan	205	98%	CV DE EN +6	US
26	Cook, Inc. Mchenry	190	100%	AN CV EN +8	US
27	Exactech, Inc. Gainesville	186	94%	DE OR	US
28	Merit Medical Systems, Inc. South Jordan	178	100%	AN CV EN +7	US
29	Osteonics Corp. Mchenry	178	76%	HO OR	US
30	Globus Medical, Inc. Audubon	172	100%	NE OR RA +1	US
31	Medtronic Sofamor Danek USA, Inc. Memphis	171	100%	DE HO NE +3	US
32	Medacta International S.A. Castel San Pietro	165	100%	NE OR RA +1	CH
33	W.L. Gore & Associates, Inc. Mchenry	163	93%	CV DE EN +8	US
34	Medtronic Sofamor Danek Memphis	154	99%	DE NE OR +1	US
35	Codman & Shurtleff, Inc. Mchenry	152	100%	CV DE GU +8	US
36	Olympus America, Inc. Lake Success	149	100%	AN CH EN +9	US
37	Richard Wolf Medical Instruments Corp. Mchenry	142	100%	AN DE EN +7	US
38	Edward Weck, Inc. Mchenry	140	100%	CV EN GU +7	US
39	Brainlab AG Heimstetten	135	100%	EN NE OR +1	DE
40	Stryker Corp. Mchenry	124	99%	AN CV DE +9	US
41	Conphar, Inc. Mchenry	122	100%	AN CV DE +9	US
42	Arthrocare Corp. Mountain View	112	100%	DE EN GU +3	US
43	Nu Vasive, Incorporated San Diego	112	100%	EN HO NE +2	US
44	Buckman Co., Inc. Mchenry	111	94%	AN CV DE +9	US
45	Arrow Intl., Inc. Mchenry	110	100%	AN CV GU +4	US
46	Intermedics Orthopedics Mchenry	108	76%	HO OR SU	US
47	Medos International SARL Raynham	64	100%	NE OR SU	US
48	Life Spine, Inc. Hoffman Estates	60	100%	OR	US
49	Stryker Portage	58	100%	DE EN NE +2	US
50	Alphatec Spine, Inc. Carlsbad	56	100%	NE OR RA	US

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.