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
16009–16032 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 06, 1991
MAY HUMERUS PLATES
K912936 · HRS
Turnkey Intergration USA, Inc.
Orthopedic · 63d
Cleared Sep 05, 1991
CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.)
K904446 · KWQ
Acromed Corp.
Orthopedic · 342d
Cleared Sep 05, 1991
MASTERPIECES(TM)/MICRO/MINI SYSTEMS
K913289 · HRS
Storz Instrument Co.
Orthopedic · 43d
Cleared Sep 04, 1991
ADG INTRAMEDULLARY BONE PLUG - VENTED
K911717 · LZN
American Design Group, Inc.
Orthopedic · 140d
Cleared Aug 29, 1991
STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST
K912190 · JDZ
Stryker Corp.
Orthopedic · 104d
Cleared Aug 29, 1991
HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC
K912263 · MEH
Zimmer, Inc.
Orthopedic · 99d
Cleared Aug 26, 1991
P.F.C. UNICONDYLAR KNEE SYSTEM
K910968 · HRY
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 173d
Cleared Aug 26, 1991
INTELIJET TM FLUID MANAGEMENT SYSTEM
K912453 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 84d
Cleared Aug 23, 1991
HUENE FIXATION SCREW
K910193 · HWC
Acu Med, Inc.
Orthopedic · 219d
Cleared Aug 21, 1991
UHMWP ACETABULAR COMPONENT
K912426 · JDI
Howmedica Corp.
Orthopedic · 82d
Cleared Aug 20, 1991
MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP
K912266 · JWH
Orothmet, Inc.
Orthopedic · 90d
Cleared Aug 19, 1991
AGC REVISION KNEE PROTHESIS
K912245 · JWH
Biomet, Inc.
Orthopedic · 90d
Cleared Aug 16, 1991
OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C
K911728 · MEH
Osteonics Corp.
Orthopedic · 121d
Cleared Aug 16, 1991
MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO
K912205 · HRX
Microaire
Orthopedic · 88d
Cleared Aug 16, 1991
MICRO-AIRE ARTHROS SURG BLADES-VARIOUS CO PROD NO.
K912206 · HRX
Microaire
Orthopedic · 88d
Cleared Aug 16, 1991
OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP
K912654 · MEH
Osteonics Corp.
Orthopedic · 60d
Cleared Aug 14, 1991
INTRAMEDULLARY HIP SCREW, MODIFICATION
K912162 · KTT
Smith & Nephew Richards, Inc.
Orthopedic · 90d
Cleared Aug 13, 1991
OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP
K912147 · JWH
Osteonics Corp.
Orthopedic · 90d
Cleared Aug 12, 1991
KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL
K912295 · LZO
Kinamed, Inc.
Orthopedic · 82d
Cleared Aug 09, 1991
INSIDE JOB
K912871 · HRX
3M Health Care, Ltd.
Orthopedic · 42d
Cleared Jul 30, 1991
ALTA CHANNEL PLATE CONNECTOR
K910482 · HRS
Howmedica Corp.
Orthopedic · 174d
Cleared Jul 26, 1991
GROSS HIP FEMORAL COMPONENT
K904737 · JDI
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 281d
Cleared Jul 26, 1991
FINN KNEE PROSTHESIS
K910877 · KRO
Biomet, Inc.
Orthopedic · 147d
Cleared Jul 26, 1991
MASTERPIECES MICRO SYSTEM
K910957 · HRS
Storz Instrument Co.
Orthopedic · 142d