FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
13585–13608 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Jun 03, 1999
MTP ARTHROPUMP DISPOSABLE TUBING SET
K990911 · HRX
Mtp Medical Technical Promotion GmbH
Orthopedic · 77d
Cleared Jun 03, 1999
UNI-CLIP STAPLE
K991482 · JDR
New Deal, S.A.
Orthopedic · 36d
Cleared Jun 03, 1999
OPERA CUPFLANGED ACETABULAR COMPONENTS
K991538 · JDI
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 31d
Cleared Jun 02, 1999
FIXION INTRAMEDULLARY NAILING SYSTEM
K990717 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 90d
Cleared Jun 02, 1999
OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR
K990922 · KWP
Howmedica Osteonics Corp.
Orthopedic · 75d
Cleared Jun 02, 1999
SYNTHES PEDIATRIC ROD SYSTEM
K991552 · MNH
Synthes (Usa)
Orthopedic · 30d
Cleared Jun 01, 1999
IMPLEX RADIAL HEAD REPLACEMENT SYSTEM
K984290 · KWI
Implex Corp.
Orthopedic · 182d
Cleared Jun 01, 1999
BONE SCREWS
K990351 · HWC
Bregma International Trading Company...
Orthopedic · 116d
Cleared Jun 01, 1999
STAINLESS STEEL FIXATION PINS
K990353 · JDW
Bregma International Trading Company...
Orthopedic · 116d