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
15097–15120 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 19, 1994
ANTERIOR CERVIAL PLATING SYSTEM
K943523 · KWQ
Smith & Nephew Richards, Inc.
Orthopedic · 151d
Cleared Dec 19, 1994
RESTORATION ACETABULAR CUP
K943549 · JDI
Osteonics Corp.
Orthopedic · 151d
Cleared Dec 19, 1994
OSTEONICS SERIES 7000 TOTAL KNEE FEMORAL COMPONENTS
K944285 · JWH
Osteonics Corp.
Orthopedic · 108d
Cleared Dec 15, 1994
HOWMEDICA SENTRY S TOTAL HIP SYSTEM
K935913 · LZO
Howmedica, Inc.
Orthopedic · 370d
Cleared Dec 15, 1994
BONE ANCHOR
K942787 · JDR
Acu Med, Inc.
Orthopedic · 185d
Cleared Dec 15, 1994
STRYKER TOTAL PERFORMANCE SYSTEM
K943589 · HWE
Stryker Corp.
Orthopedic · 146d
Cleared Dec 15, 1994
ORTHOLOC ADVANTIM MODULAR FEMORAL AUGMENT COMPONENT
K944845 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 76d
Cleared Dec 12, 1994
ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS
K940230 · HRX
Instratek, Inc.
Orthopedic · 332d
Cleared Dec 09, 1994
EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT
K935773 · JWH
Exactech, Inc.
Orthopedic · 371d
Cleared Dec 09, 1994
APR II NON POROUS HIP STEM
K944209 · LZO
Intermedics Orthopedics
Orthopedic · 102d
Cleared Dec 09, 1994
6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW
K944213 · HWC
Howmedica Corp.
Orthopedic · 102d
Cleared Dec 08, 1994
OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS
K941128 · JWH
Osteonics Corp.
Orthopedic · 274d
Cleared Dec 08, 1994
BONE SCREW
K943804 · HWC
Cohort Medical Products Group, Inc.
Orthopedic · 126d
Cleared Dec 08, 1994
P.F.C. APICAL PLUG
K944769 · JDL
Johnson & Johnson Professionals, Inc.
Orthopedic · 72d
Cleared Dec 06, 1994
PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI
K931466 · JWH
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 622d
Cleared Dec 06, 1994
KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS
K943154 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 159d
Cleared Dec 05, 1994
WEBB-MORLEY SPINE SYSTEM
K941367 · KWQ
Electro-Biology, Inc.
Orthopedic · 259d
Cleared Dec 05, 1994
CORTICAL BONE SCREW
K942340 · HWC
Acu Med, Inc.
Orthopedic · 203d
Cleared Dec 05, 1994
CANNULATED CANCELLOUS BONE SCREW
K942341 · HWC
Acu Med, Inc.
Orthopedic · 203d
Cleared Nov 30, 1994
PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM
K930771 · JDI
Orthomet, Inc.
Orthopedic · 652d
Cleared Nov 28, 1994
ZIRCONIA CERAMIC FEMORAL HEAD
K935921 · LZO
Smith & Nephew Richards, Inc.
Orthopedic · 376d
Cleared Nov 28, 1994
PIONEER LABORATORIES CABLE SCREW
K941866 · HWC
Pioneer Surgical Technology
Orthopedic · 224d
Cleared Nov 28, 1994
STRYKER SURGICAL INSTRUMENTS AND ACCESSORIES
K943323 · HRX
Stryker Corp.
Orthopedic · 140d
Cleared Nov 28, 1994
TRUE/FLEX INTRAMEDULLARY ROD END-CAP
K944501 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 75d