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
12001–12024 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 24, 2003
MODIFICATION TO MODULAR PLUS REVISION STEM
K030971 · LWJ
Plus Orthopedics
Orthopedic · 27d
Cleared Apr 24, 2003
MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K030979 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Apr 24, 2003
MODIFICATION TO XIA STAINLESS STEEL SYSTEM
K031090 · KWP
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Apr 22, 2003
MASTERGRAFT MATRIX
K023553 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 181d
Cleared Apr 22, 2003
SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM
K030310 · HRS
Synthes (Usa)
Orthopedic · 82d
Cleared Apr 18, 2003
LEFORTE SYSTEM BONE SCREW
K023365 · HWC
Jeil Medical Corporation
Orthopedic · 193d
Cleared Apr 18, 2003
MODIFIED VERTE-STACK SPINAL SYSTEM
K030735 · MQP
Medtronic Sofamor Danek
Orthopedic · 39d
Cleared Apr 18, 2003
SYNTHES ANTERIOR CSLP SYSTEM
K030866 · KWQ
Synthes (Usa)
Orthopedic · 30d
Cleared Apr 17, 2003
ARTHROSCOPY PUMP, MODEL A107
K030402 · HRX
W.O.M. World of Medicine AG
Orthopedic · 70d
Cleared Apr 17, 2003
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR
K030862 · MNI
Blackstone Medical, Inc.
Orthopedic · 30d
Cleared Apr 10, 2003
CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
K023096 · HSD
Std Mfg., Inc.
Orthopedic · 204d
Cleared Apr 10, 2003
CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM
K030151 · LZO
Hayes Medical, Inc.
Orthopedic · 85d
Cleared Apr 10, 2003
DEPUY ACROMED VBR SYSTEM
K030833 · MQP
Depuyacromed
Orthopedic · 24d
Cleared Apr 10, 2003
AVANTA CARPAL FUSION PLATING SYSTEM
K030881 · HRS
Avanta Orthopaedics, Inc.
Orthopedic · 21d
Cleared Apr 10, 2003
AAP ACROPLATE
K030909 · HRS
Aap Implantate AG
Orthopedic · 17d
Cleared Apr 08, 2003
TETRIS SPINAL IMPLANT
K022793 · MQP
Signus Medical, LLC
Orthopedic · 228d
Cleared Apr 04, 2003
SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS
K030858 · HRS
Synthes (Usa)
Orthopedic · 17d
Cleared Apr 02, 2003
KSEA POWERSHAVER SYSTEM S2
K030009 · HRX
Karl Storz Endoscopy
Orthopedic · 90d
Cleared Apr 02, 2003
OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT
K030686 · JWH
Exactech, Inc.
Orthopedic · 28d
Cleared Apr 02, 2003
VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES
K030736 · MQP
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Apr 01, 2003
CONSTRAINED LINER
K023794 · KWZ
Encore Medical, L.P.
Orthopedic · 139d
Cleared Apr 01, 2003
ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32
K030153 · JDI
Zimmer, Inc.
Orthopedic · 75d
Cleared Apr 01, 2003
HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM
K030198 · HRS
Hand Innovations, Inc.
Orthopedic · 70d
Cleared Apr 01, 2003
CONSENSUS UNIPOLAR HEAD, COCR
K030205 · KWL
Hayes Medical, Inc.
Orthopedic · 70d