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
13249–13272 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 04, 2000
POROCOAT PRODIGY HIP PROSTHESIS
K000207 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 11d
Cleared Feb 04, 2000
WILTSE SYSTEM
K992012 · KWQ
Advanced Spine Fixation Systems, Inc.
Orthopedic · 234d
Cleared Feb 04, 2000
ACUMED MODULAR SHOULDER SYSTEM
K992525 · HSD
Acu Med, Inc.
Orthopedic · 191d
Cleared Feb 04, 2000
I.CO.S SCREW
K993762 · HWC
New Deal, S.A.
Orthopedic · 88d
Cleared Feb 04, 2000
ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH...
K993943 · MEH
Encore Orthopedics, Inc.
Orthopedic · 77d
Cleared Feb 04, 2000
MALLORY/HEAD SMOOTH FEMORAL COMPONENT
K994007 · JDI
Biomet, Inc.
Orthopedic · 72d
Cleared Feb 04, 2000
DOGBONE ACFS
K994383 · KWQ
Theken Surgical
Orthopedic · 38d
Cleared Feb 03, 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K000020 · MNH
Encore Orthopedics, Inc.
Orthopedic · 30d
Cleared Feb 03, 2000
EBI XFIX DFS RAIL SYSTEM
K000083 · KTT
Ebi, L.P.
Orthopedic · 22d
Cleared Feb 03, 2000
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
K000089 · HWC
Synthes (Usa)
Orthopedic · 22d
Cleared Feb 03, 2000
DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
K000172 · HRY
DePuy Orthopaedics, Inc.
Orthopedic · 14d
Cleared Feb 03, 2000
CD HORIZON SPINAL SYSTEM
K993810 · MNH
Danek Medical, Inc.
Orthopedic · 85d
Cleared Feb 03, 2000
MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS
K994415 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 36d
Cleared Feb 01, 2000
TAC' PIN
K993910 · JDW
New Deal, S.A.
Orthopedic · 76d
Cleared Jan 28, 2000
ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU
K990340 · MAI
Arthrex, Inc.
Orthopedic · 359d
Cleared Jan 28, 2000
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K991162 · LZO
Smith & Nephew, Inc.
Orthopedic · 296d
Cleared Jan 28, 2000
RIM-FIX, ACETABULAR CUP
K993713 · JDI
Surgical Implants, Inc.
Orthopedic · 86d
Cleared Jan 21, 2000
MRP-TITAN
K992403 · LZO
Rotec Medizintechnik GmbH
Orthopedic · 186d
Cleared Jan 21, 2000
CITATION TMZF HA STEM
K993768 · MEH
Howmedica Osteonics Corp.
Orthopedic · 74d
Cleared Jan 20, 2000
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT
K993736 · LPH
Exactech, Inc.
Orthopedic · 77d
Cleared Jan 20, 2000
REVELATION POROUS HIP STEM
K994070 · LPH
Encore Orthopedics, Inc.
Orthopedic · 49d
Cleared Jan 13, 2000
BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B
K990987 · MAI
Arthrex, Inc.
Orthopedic · 295d
Cleared Jan 13, 2000
MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS)
K991862 · MNI
Micomed GmbH
Orthopedic · 226d
Cleared Jan 13, 2000
SOCON SPINAL SYSTEM
K993551 · MNH
Aesculap, Inc.
Orthopedic · 86d