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
13225–13248 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 25, 2000
ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS
K000232 · JWH
Corin USA
Orthopedic · 29d
Cleared Feb 25, 2000
EBI XFIX DFS SYSTEM
K000319 · KTT
Ebi, L.P.
Orthopedic · 23d
Cleared Feb 25, 2000
MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM
K000335 · LPH
Biomet, Inc.
Orthopedic · 22d
Cleared Feb 25, 2000
RADIAL HEAD PROSTHESIS
K992220 · KWI
Smith & Nephew, Inc.
Orthopedic · 239d
Cleared Feb 25, 2000
MEMOGRAPH STAPLE, WARM SYSTEM
K993714 · JDR
Biomedical Ent., Inc.
Orthopedic · 115d
Cleared Feb 25, 2000
CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS
K994153 · KXA
Corin USA
Orthopedic · 79d
Cleared Feb 25, 2000
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS...
K994202 · HWC
Smith & Nephew, Inc.
Orthopedic · 74d
Cleared Feb 18, 2000
MRS-TITAN
K992359 · LZO
Rotec Medizintechnik GmbH
Orthopedic · 219d
Cleared Feb 18, 2000
IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED...
K994076 · JWH
Implex Corp.
Orthopedic · 78d
Cleared Feb 18, 2000
BONE GRAFT WASHER, MODEL 9090114 - 9090118
K994122 · KWQ
Danek Medical, Inc.
Orthopedic · 73d
Cleared Feb 18, 2000
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL...
K994143 · JDW
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared Feb 16, 2000
SYNERGY VLS CAP NUT MODELS 2206, 6102
K000236 · MNI
Interpore Cross Intl.
Orthopedic · 20d
Cleared Feb 16, 2000
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES...
K000242 · MEH
Exactech, Inc.
Orthopedic · 20d
Cleared Feb 16, 2000
IMPACT MODULAR TOTAL HIP SYSTEM
K000334 · LPH
Biomet, Inc.
Orthopedic · 13d
Cleared Feb 16, 2000
MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM
K994425 · HRX
Endius, Inc.
Orthopedic · 48d
Cleared Feb 15, 2000
PLR SPLINED REVISION STEM
K994184 · LZO
Biomet, Inc.
Orthopedic · 67d
Cleared Feb 14, 2000
WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013
K993903 · JDQ
Whiteside Biomechanics, Inc.
Orthopedic · 90d
Cleared Feb 14, 2000
LOCON-T DISTAL RADIAL PLATE
K994061 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 75d
Cleared Feb 11, 2000
EXETER CERAMIC FEMORAL HEADS
K993889 · LZO
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Feb 08, 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K000094 · MNH
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 26d
Cleared Feb 08, 2000
ARTHRO-SURGIMAT-A103
K000153 · HRX
W.O.M. World of Medicine GmbH
Orthopedic · 21d
Cleared Feb 08, 2000
CLICK'X
K992739 · MNH
Synthes Spine
Orthopedic · 176d
Cleared Feb 07, 2000
PAR 5 ACETABULAR COMPONENT
K000254 · JDI
Biomet, Inc.
Orthopedic · 10d
Cleared Feb 07, 2000
THE MARGRON HIP REPLACEMENT SYSTEM
K992815 · MEH
Portland Orthopaedics Pty. , Ltd.
Orthopedic · 171d