FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
12865–12888 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 20, 2001
APEX MODULAR ZIRCONIA FEMORAL HEAD
K003923 · LZO
Apex Surgical, LLC
Orthopedic · 90d
Cleared Mar 20, 2001
MODIFICATION TO TRIDENT ALL POLY CUP
K010310 · JDI
Howmedica Osteonics Corp.
Orthopedic · 47d
Cleared Mar 20, 2001
PORTRAIT FEMORAL COMPONENT
K010560 · LZO
Biomet, Inc.
Orthopedic · 22d
Cleared Mar 19, 2001
NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING...
K003910 · JWH
Zimmer, Inc.
Orthopedic · 90d
Cleared Mar 19, 2001
BAUMER CEMENTED HIP PROSTHESIS
K003975 · JDI
Baumer, S.A
Orthopedic · 87d
Cleared Mar 19, 2001
BAUMER MULLER HIP PROSTHESIS
K003976 · JDI
Baumer, S.A
Orthopedic · 87d
Cleared Mar 19, 2001
SUPER REVO SUTURE ANCHOR
K003984 · MAI
Linvatec Corp.
Orthopedic · 83d
Cleared Mar 19, 2001
TRIFIX SPINAL FIXATION SYSTEM
K010535 · MNH
Endius, Inc.
Orthopedic · 24d
Cleared Mar 13, 2001
MEMOGRAPH
K001354 · JDR
Biomedical Ent., Inc.
Orthopedic · 319d
Cleared Mar 13, 2001
TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)
K003911 · KWP
Terray Corp.
Orthopedic · 84d
Cleared Mar 13, 2001
OPTETRAK B-SERIES TOTAL KNEE SYSTEM
K010434 · JWH
Exactech, Inc.
Orthopedic · 28d
Cleared Mar 13, 2001
MODIFICATION TO EBI XFIX DFS RAIL SYSTEM
K010437 · KTT
Ebi, L.P.
Orthopedic · 28d
Cleared Mar 09, 2001
ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM,...
K003816 · HWC
Arthrex, Inc.
Orthopedic · 88d
Cleared Mar 09, 2001
MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM
K010367 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 30d
Cleared Mar 07, 2001
SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW
K002274 · HWC
Smith & Nephew, Inc.
Orthopedic · 224d
Cleared Mar 07, 2001
ALLOFIT ACETABULAR SYSTEM
K003758 · KWA
Sulzer Orthopedics, Inc.
Orthopedic · 91d
Cleared Mar 06, 2001
SHAVER ABLATOR
K002088 · HRX
Linvatec Corp.
Orthopedic · 238d
Cleared Mar 01, 2001
TI-REPLICA HIP STEM
K003875 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 76d
Cleared Mar 01, 2001
VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL...
K003893 · HRX
Oratec Interventions, Inc.
Orthopedic · 73d
Cleared Feb 28, 2001
ANATOMICAL PRESS-FIT HUMERAL STEM
K003801 · KWS
Sulzer Orthopedics, Inc.
Orthopedic · 82d
Cleared Feb 23, 2001
FREEDLAND TENSION SYSTEM
K003648 · MBI
Etzem Technologies, Inc.
Orthopedic · 88d
Cleared Feb 23, 2001
TRITON HIP SYSTEM
K003649 · LWJ
Hayes Medical, Inc.
Orthopedic · 88d
Cleared Feb 23, 2001
CD HORIZON SPINAL SYSTEM
K010249 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Feb 22, 2001
MTP RESESURFACING JOINT-SMALL/9301-01
K003629 · KWD
Terray Corp.
Orthopedic · 90d