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
13441–13464 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 14, 1999
DEPUY ROCKWOOD CLAVICLE PIN
K991649 · JDW
Depuy, Inc.
Orthopedic · 62d
Cleared Jul 14, 1999
COBREX HIP STEM, MODEL 01-128-XXXXX
K991869 · JDI
Implex Corp.
Orthopedic · 43d
Cleared Jul 12, 1999
TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE
K990135 · LPH
Zimmer, Inc.
Orthopedic · 180d
Cleared Jul 12, 1999
SYNERGY POROUS SIZE 8 HIP STEM
K991485 · LPH
Smith & Nephew, Inc.
Orthopedic · 75d
Cleared Jul 12, 1999
GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE...
K992065 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Jul 08, 1999
STAINLESS STEEL SOFT SUTURE WIRE
K990355 · LRN
Bregma International Trading Company...
Orthopedic · 153d
Cleared Jul 08, 1999
TITANIUM LOW PROFILE SCREWS
K991807 · LPH
Biomet, Inc.
Orthopedic · 43d
Cleared Jul 01, 1999
HEDROCEL ACETABULAR CAGE SYSTEM
K983837 · LPH
Implex Corp.
Orthopedic · 244d
Cleared Jul 01, 1999
BIO-INTERFERENCE SCREW
K990454 · HWC
Innovasive Devices, Inc.
Orthopedic · 139d
Cleared Jul 01, 1999
SYNTHES CERVIFIX SYSTEM
K990965 · KWP
Synthes (Usa)
Orthopedic · 101d
Cleared Jul 01, 1999
BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM
K992058 · JDI
Biomet, Inc.
Orthopedic · 13d
Cleared Jun 29, 1999
OMNI-FIX, HUMERAL NAIL
K991405 · KTW
Turnkey Intergration USA, Inc.
Orthopedic · 68d
Cleared Jun 29, 1999
GRIT BLASTED HUMERAL STEM
K991603 · KWT
Encore Orthopedics, Inc.
Orthopedic · 50d
Cleared Jun 29, 1999
OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS
K991952 · LZO
Howmedica Osteonics Corp.
Orthopedic · 19d
Cleared Jun 28, 1999
SYNERGY ADJUSTABLE LENGTH ROD
K990057 · MNI
Interpore Cross Intl.
Orthopedic · 172d
Cleared Jun 28, 1999
COLOR BUFFED ANSWER CEMENTED FEMORAL
K991987 · JDI
Biomet, Inc.
Orthopedic · 14d
Cleared Jun 25, 1999
MODIFICATION OF ENCORE LINEAR POROUS COATED HIP
K991325 · LPH
Encore Orthopedics, Inc.
Orthopedic · 67d
Cleared Jun 23, 1999
RC BUTTRESS
K991009 · MAI
Biomet, Inc.
Orthopedic · 89d
Cleared Jun 23, 1999
EUCLID REDUCTION AND GUIDANCE SYSTEM
K991037 · JDS
Modular Cutting Systems, Inc.
Orthopedic · 86d
Cleared Jun 23, 1999
METACARPAL FIXATION SYSTEM
K991064 · HTY
Medcanica, Inc.
Orthopedic · 84d
Cleared Jun 11, 1999
IMPLEX ALUMINA FEMORAL HEAD
K990183 · LZO
Implex Corp.
Orthopedic · 142d
Cleared Jun 11, 1999
MAGNA-ROM 21 KNEE SYSTEEM
K991143 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 67d
Cleared Jun 11, 1999
SYNTHES LOCKING CALCANEAL PLATES
K991407 · LXT
Synthes (Usa)
Orthopedic · 50d
Cleared Jun 09, 1999
P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY
K991106 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 69d