FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
11953–11976 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 01, 2003
DISTAL RADIUS FRACTURE REPAIR SYSTEM
K032705 · LXT
Hand Innovations, Inc.
Orthopedic · 29d
Cleared Oct 01, 2003
TRIGEN STRAIGHT HUMERAL NAIL SYSTEM
K032722 · HSB
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Sep 29, 2003
DEPUY 1 GENTAMICIN BONE CEMENT
K023103 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 376d
Cleared Sep 26, 2003
DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS
K032151 · JWH
Depuy, Inc.
Orthopedic · 74d
Cleared Sep 26, 2003
IRRIGATION SETS
K032832 · HRX
Vital Concepts, Inc.
Orthopedic · 15d
Cleared Sep 24, 2003
GLOBAL CAP RESURFACING REPLACEMENT SHOULDER
K031971 · HSD
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Sep 23, 2003
PALACOS R
K030902 · LOD
Heraeus Kulzer GmbH & Co. KG
Orthopedic · 183d
Cleared Sep 23, 2003
OSTEOPAL
K030903 · LOD
Heraeus Kulzer GmbH & Co. KG
Orthopedic · 183d
Cleared Sep 23, 2003
PALAMED
K030904 · LOD
Heraeus Medical GmbH Technology
Orthopedic · 183d
Cleared Sep 23, 2003
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
K031214 · KWQ
Encore Medical, L.P.
Orthopedic · 159d
Cleared Sep 23, 2003
MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE...
K031449 · KWS
Implex Corp.
Orthopedic · 139d
Cleared Sep 23, 2003
OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6...
K032606 · JWH
Exactech, Inc.
Orthopedic · 29d
Cleared Sep 23, 2003
MODULAR PLUS HIP STEM
K032709 · LWJ
Plus Orthopedics
Orthopedic · 21d
Cleared Sep 22, 2003
MODIFICATION TO HIGHGATE CURVED ROD SYSTEM
K023983 · KWQ
Highgate Orthopaedics
Orthopedic · 294d
Cleared Sep 22, 2003
HALM ZIELKE INSTRUMENTATION SYSTEM
K024125 · KWQ
Micomed Ortho GmbH
Orthopedic · 280d
Cleared Sep 22, 2003
ESKA MODULAR HIP SYSTEM CEMENTED
K030867 · JDI
Eska Implants GmbH
Orthopedic · 187d
Cleared Sep 22, 2003
ARTHREX TRIMIT SCREW, MODEL AR-4161B
K031945 · HWC
Arthrex, Inc.
Orthopedic · 90d
Cleared Sep 22, 2003
PROCLASS PRESS FIT HIP STEM
K032110 · LWJ
Stelkast Company
Orthopedic · 75d
Cleared Sep 22, 2003
CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)
K032169 · LXT
Cyberorthology, Inc.
Orthopedic · 68d
Cleared Sep 22, 2003
ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM
K032187 · HRS
Arthrex, Inc.
Orthopedic · 67d
Cleared Sep 22, 2003
WAGNER CONE PROSTHESIS
K032380 · LZO
Centerpulse Orthopedics, Inc.
Orthopedic · 52d
Cleared Sep 17, 2003
SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM
K031855 · KWQ
Spinal Concepts, Inc.
Orthopedic · 93d
Cleared Sep 17, 2003
TSRH SPINAL SYSTEM
K031967 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 83d
Cleared Sep 17, 2003
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K032269 · HRS
Synthes (Usa)
Orthopedic · 56d