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
15793–15816 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 26, 1992
MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS
K912837 · KWP
Kirschner Medical Corp.
Orthopedic · 427d
Cleared Aug 18, 1992
DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS
K915512 · JWH
Pfizer Hospital Products Group, Inc.
Orthopedic · 253d
Cleared Aug 18, 1992
ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS
K922391 · HRX
Instratek, Inc.
Orthopedic · 90d
Cleared Aug 13, 1992
AGC AND MAXIM KNEE COMPONENTS WITH NTS
K922285 · JWH
Biomet, Inc.
Orthopedic · 90d
Cleared Aug 11, 1992
7000 SERIES TOTAL KNEE MODULAR COMPONENT CEMENT CA
K922104 · JWH
Osteonics Corp.
Orthopedic · 97d
Cleared Aug 11, 1992
OSTRONCS HEMI-HIP STEM SERIES
K922146 · KWL
Osteonics Corp.
Orthopedic · 96d
Cleared Aug 10, 1992
AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE
K910992 · JWH
Depuy, Inc.
Orthopedic · 522d
Cleared Aug 10, 1992
DOUGLAS MEDICAL PRODUCTS, INC. IRRIGATION SET
K922318 · HRX
Douglas Medical Products Corp.
Orthopedic · 84d
Cleared Aug 07, 1992
MODULAR FEMORAL HEAD WITH OFFSET TRUNION
K914675 · JDI
Kirschner Medical Corp.
Orthopedic · 294d
Cleared Aug 07, 1992
KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM
K920396 · JWH
Kirschner Medical Corp.
Orthopedic · 190d
Cleared Aug 07, 1992
INTER-HA HIP PROSTHESIS
K921672 · MEH
Kirschner Medical Corp.
Orthopedic · 121d
Cleared Aug 06, 1992
ALPHATEC SMALL FRAGMENT SET
K922166 · HWC
Alphatec Mfg., Inc.
Orthopedic · 90d
Cleared Aug 06, 1992
ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES
K922167 · HRS
Alphatec Mfg., Inc.
Orthopedic · 90d
Cleared Aug 05, 1992
INTRAMEDULARY FIXATION ROD
K920666 · HSB
Acu Med, Inc.
Orthopedic · 174d
Cleared Aug 05, 1992
CITSCOPE (MODEL EXTENSIONS)
K922144 · HRX
Citation Medical Corp.
Orthopedic · 91d
Cleared Aug 05, 1992
ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW
K922322 · HWC
Alphatec Mfg., Inc.
Orthopedic · 79d
Cleared Aug 03, 1992
PSK FEMORAL AND TIBIAL INSERT COMPONENT
K920426 · JWH
Orthomet, Inc.
Orthopedic · 182d
Cleared Aug 03, 1992
FEMORAL AND ALL POLY TIBIAL TRAY COMPONENTS
K920698 · JWH
Orthomet, Inc.
Orthopedic · 182d
Cleared Jul 30, 1992
ZIRCONIUM ALLOY FRMORAL HEAD
K914878 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 274d
Cleared Jul 30, 1992
CDH HIP SYSTEM
K922008 · JDI
Howmedica, Pfizer Medical Technology...
Orthopedic · 91d
Cleared Jul 27, 1992
ACE 100 DEGREES TUBULAR PLATE
K920738 · HRS
Ace Orthopedic Manufacturing Co.
Orthopedic · 159d
Cleared Jul 23, 1992
OSTEO KIRSCHNER WIRE
K922193 · HTY
Osteo AG
Orthopedic · 73d
Cleared Jul 23, 1992
OSTEO STEINMANN PIN
K922194 · HTY
Osteo AG
Orthopedic · 73d
Cleared Jul 23, 1992
OSTEO FEMORAL NAIL
K922195 · HSB
Osteo AG
Orthopedic · 73d