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
15937–15960 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 20, 1991
BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS
K912712 · JDI
Biomet, Inc.
Orthopedic · 184d
Cleared Dec 20, 1991
S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD
K913231 · JDI
Joint Medical Products Corp.
Orthopedic · 151d
Cleared Dec 20, 1991
PT II DISTAL CEMENT SPACER
K914406 · JDI
Osteonics Corp.
Orthopedic · 79d
Cleared Dec 19, 1991
NUCLEOTOME TISSUE ASPIRATOR/CUTTER
K913145 · HRX
Surgical Dynamics, Inc.
Orthopedic · 156d
Cleared Dec 19, 1991
NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER
K914282 · HRX
Surgical Dynamics, Inc.
Orthopedic · 86d
Cleared Dec 19, 1991
CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW
K915187 · HWC
Techmedica, Inc.
Orthopedic · 31d
Cleared Dec 18, 1991
EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO
K914269 · KWP
Scientific Spinal , Ltd.
Orthopedic · 85d
Cleared Dec 16, 1991
APR II HIP SYSTEM
K913634 · JDI
Intermedics Orthopedics
Orthopedic · 123d
Cleared Dec 16, 1991
AXIOM TOTAL KNEE SYSTEM, ALL POLY TIBIAL TRAY
K914230 · JWH
Orthomet, Inc.
Orthopedic · 87d
Cleared Dec 09, 1991
3M FLUID CONTROL SYSTEM SMALL JOINT COPS CANNULA
K912099 · HRX
3M Company
Orthopedic · 210d
Cleared Dec 09, 1991
HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT
K913916 · MEH
Smith & Nephew Richards, Inc.
Orthopedic · 97d
Cleared Dec 09, 1991
DEPUY (NITINO) GUIDE WIRE
K914693 · JDQ
Depuy, Inc.
Orthopedic · 52d
Cleared Dec 05, 1991
ALPHATEC CANNULATED BONE SCREWS
K914004 · HWC
Alphatec Mfg., Inc.
Orthopedic · 90d
Cleared Dec 05, 1991
KINAMED CTN STEM
K914237 · LZO
Kinamed, Inc.
Orthopedic · 76d
Cleared Dec 04, 1991
GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE
K914000 · KWT
Depuy, Inc.
Orthopedic · 89d
Cleared Dec 02, 1991
LUHR PAN FIXATION SYSTEM
K913355 · HRS
Howmedica Corp.
Orthopedic · 126d
Cleared Nov 29, 1991
ANGLED BLADE PLATE
K914546 · KTW
Synthes (Usa)
Orthopedic · 49d
Cleared Nov 27, 1991
ACE CORTICAL BONE SCREW
K912598 · HWC
Ace Medical Co.
Orthopedic · 170d
Cleared Nov 27, 1991
BIOPRO ZIRALLOY MODULAR FEMORAL HEADS
K912641 · LZO
Biopro, Inc.
Orthopedic · 166d
Cleared Nov 27, 1991
INFINITY(TM) MICROTAPER HIP SYSTEM
K913874 · JDI
Dow Corning Wright
Orthopedic · 90d
Cleared Nov 22, 1991
TOWNLEY GREAT TOE JOINT
K911378 · KWD
Biopro, Inc.
Orthopedic · 239d
Cleared Nov 22, 1991
MAKAR MINI CANNULATED CANCELLOUS SCREWS
K912021 · HWC
Instrument Makar, Inc.
Orthopedic · 199d
Cleared Nov 22, 1991
OSTEO BONE SCREWS
K913269 · HWC
Fred C. Bryson
Orthopedic · 122d
Cleared Nov 22, 1991
TOTAL HIP PROSTHESIS- FEMORAL COMPONENTS
K913633 · LZO
Intermedics Orthopedics
Orthopedic · 99d