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
13465–13488 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 03, 1999
MTP ARTHROPUMP DISPOSABLE TUBING SET
K990911 · HRX
Mtp Medical Technical Promotion GmbH
Orthopedic · 77d
Cleared Jun 03, 1999
UNI-CLIP STAPLE
K991482 · JDR
New Deal, S.A.
Orthopedic · 36d
Cleared Jun 03, 1999
OPERA CUPFLANGED ACETABULAR COMPONENTS
K991538 · JDI
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 31d
Cleared Jun 02, 1999
FIXION INTRAMEDULLARY NAILING SYSTEM
K990717 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 90d
Cleared Jun 02, 1999
OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR
K990922 · KWP
Howmedica Osteonics Corp.
Orthopedic · 75d
Cleared Jun 02, 1999
SYNTHES PEDIATRIC ROD SYSTEM
K991552 · MNH
Synthes (Usa)
Orthopedic · 30d
Cleared Jun 01, 1999
IMPLEX RADIAL HEAD REPLACEMENT SYSTEM
K984290 · KWI
Implex Corp.
Orthopedic · 182d
Cleared Jun 01, 1999
BONE SCREWS
K990351 · HWC
Bregma International Trading Company...
Orthopedic · 116d
Cleared Jun 01, 1999
STAINLESS STEEL FIXATION PINS
K990353 · JDW
Bregma International Trading Company...
Orthopedic · 116d
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