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
13609–13632 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 01, 1999
KSEA EPIDUROSCOPE
K991051 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 63d
Cleared Jun 01, 1999
PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM
K991123 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 60d
Cleared Jun 01, 1999
FOUNDATION POROUS HIP STEM
K991226 · LZO
Encore Orthopedics, Inc.
Orthopedic · 50d
Cleared Jun 01, 1999
8MM FORGED CEMENTED STEM
K991227 · JDI
Encore Orthopedics, Inc.
Orthopedic · 50d
Cleared May 28, 1999
MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
K991528 · MNH
Danek Medical, Inc.
Orthopedic · 25d
Cleared May 27, 1999
ISOLOCK SPINAL SYSTEM
K990721 · MNH
Scien'Tx USA, Inc.
Orthopedic · 83d
Cleared May 21, 1999
ASCENT KNEE SYSTEM
K991428 · JWH
Biomet, Inc.
Orthopedic · 25d
Cleared May 21, 1999
CENTRAFIX EXTERNAL FIXATOR
K991732 · JEC
Owandar Medical, Ltd.
Orthopedic
Cleared May 19, 1999
MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
K991364 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 29d
Cleared May 19, 1999
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K991460 · MNH
Sofamor Danek
Orthopedic · 22d
Cleared May 17, 1999
TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION...
K990848 · LXT
Immedica, Inc.
Orthopedic · 63d
Cleared May 17, 1999
OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERT
K991461 · JWH
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared May 14, 1999
BONE MULCH SCREW SYSTEM
K991298 · HWC
Biomet, Inc.
Orthopedic · 29d
Cleared Apr 30, 1999
SINGLE AXLE TOTAL ELBOW
K983036 · JDC
Biomet, Inc.
Orthopedic · 242d
Cleared Apr 30, 1999
OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY
K984375 · KWP
Osteonics Corp.
Orthopedic · 144d
Cleared Apr 30, 1999
B2C, ESPACE REVISION CUP SYSTEM
K990523 · LPH
Turnkey Intergration USA, Inc.
Orthopedic · 70d
Cleared Apr 29, 1999
BUECHEL-PAPPAS MODULAR SALVAGE STEM
K982418 · MJT
Endotec, Inc.
Orthopedic · 290d
Cleared Apr 29, 1999
ROTORBLADE
K983435 · MAI
Li Medical Technologies, Inc.
Orthopedic · 212d
Cleared Apr 29, 1999
ENDOPEARL
K984171 · MAI
Linvatec Corp.
Orthopedic · 160d
Cleared Apr 29, 1999
EBI OMEGA 21 SYSTEM
K990303 · KWP
Electro-Biology, Inc.
Orthopedic · 87d
Cleared Apr 29, 1999
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
K990596 · HRS
Avanta Orthopaedics, Inc.
Orthopedic · 64d
Cleared Apr 29, 1999
BOLD SCREW
K990622 · HWC
New Deal, S.A.
Orthopedic · 63d
Cleared Apr 29, 1999
AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
K990776 · HWC
Aap Implantate AG
Orthopedic · 51d
Cleared Apr 29, 1999
STAYFUSE
K990804 · HWC
Pioneer Surgical Technology
Orthopedic · 50d