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
11809–11832 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 09, 2003
T2 RECON NAIL SYSTEM
K032898 · HSB
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Oct 08, 2003
ENDOTINE FOREHEAD DEVICE
K032770 · HWC
Coapt Systems, Inc.
Orthopedic · 30d
Cleared Oct 07, 2003
ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE,...
K032098 · HWC
Arthrex, Inc.
Orthopedic · 91d
Cleared Oct 07, 2003
NUVASIVE CEMENT RESTRICTOR
K032180 · JDK
Nuvasive, Inc.
Orthopedic · 82d
Cleared Oct 06, 2003
NORMED COMPRESSION BONE SCREW SYSTEM
K032634 · JDS
Noviace Corporation
Orthopedic · 41d
Cleared Oct 06, 2003
ACE NANCY NAIL
K032687 · HTY
DePuy Orthopaedics, Inc.
Orthopedic · 38d
Cleared Oct 03, 2003
EPSILON DURASUL CONSTRAINED ACETABULAR LINER
K030923 · KWZ
Centerpulse Orthopedics, Inc.
Orthopedic · 193d
Cleared Oct 02, 2003
HLS NOETOS SYSTEM
K032079 · JWH
Tornier
Orthopedic · 87d
Cleared Oct 01, 2003
LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE
K032072 · HWC
Arthrotek, Inc.
Orthopedic · 90d
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