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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,816 results
10345–10368 of 17,816
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 13, 2006
SALTO TALARIS TOTAL ANKLE PROSTHESIS
K060544 · HSN
Tornier
Orthopedic · 257d
Cleared Nov 13, 2006
SBI LATERAL RHEAD IMPLANT
K062898 · KWI
Small Bone Innovations, Inc.
Orthopedic · 47d
Cleared Nov 13, 2006
ORTHROPRO HEMI TOE
K062908 · KWD
Orthopro, LLC
Orthopedic · 47d
Cleared Nov 13, 2006
ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP
K062920 · KTW
Orthofix Srl
Orthopedic · 46d
Cleared Nov 09, 2006
INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001
K062782 · MAI
Inion OY
Orthopedic · 52d
Cleared Nov 09, 2006
AEQUALIS SHOULDER SYSTEM
K063081 · HSD
Tornier
Orthopedic · 30d
Cleared Nov 06, 2006
TSRH SPINAL SYSTEM
K062807 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 48d
Cleared Nov 06, 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K063083 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Nov 03, 2006
CONFIDENCE FENESTRATED INTRODUCER NEEDLE
K063067 · NDN
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 28d
Cleared Nov 02, 2006
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K062174 · MNH
Depuy Spine, Inc.
Orthopedic · 94d
Cleared Nov 01, 2006
MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT
K063033 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 29d
Cleared Oct 31, 2006
MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS
K061925 · HTN
Arthrex, Inc.
Orthopedic · 116d
Cleared Oct 31, 2006
ANATOMICAL SHOULDER FRACTURE SYSTEM
K062029 · KWS
Zimmer GmbH
Orthopedic · 105d
Cleared Oct 31, 2006
ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM
K062861 · HSD
Ascension Orthopedics, Inc.
Orthopedic · 36d
Cleared Oct 31, 2006
OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM
K062863 · HWC
Osteomed LP
Orthopedic · 36d
Cleared Oct 31, 2006
M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT
K062995 · KWA
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Oct 31, 2006
ALTRA PRESS-FIT HIP SYSTEM
K063002 · KWA
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Oct 25, 2006
CD HORIZON SPINAL SYSTEM
K060615 · NKB
Medtronic Sofamor Danek
Orthopedic · 232d
Cleared Oct 25, 2006
MALIBU SPINAL SYSTEM
K061342 · NKB
Seaspine, Inc.
Orthopedic · 193d
Cleared Oct 25, 2006
DARCO FORCE TITANIUM COMPRESSION SCREW
K062103 · HWC
Darco International, Inc.
Orthopedic · 93d
Cleared Oct 25, 2006
PROFYLE SYSTEM
K062498 · HRS
Howmedica Osteonics Corp.
Orthopedic · 61d
Cleared Oct 24, 2006
DEPUY PINNACLE ALTRX ACETABULAR CUP LINER
K062148 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 89d
Cleared Oct 24, 2006
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
K062853 · MNI
Stryker Spine
Orthopedic · 29d
Cleared Oct 20, 2006
SBI CARPAL FUSION PLATE
K062903 · HRS
Small Bone Innovations, Inc.
Orthopedic · 23d