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
11977–12000 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 28, 2003
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
K031219 · HSB
Orthofix, Inc.
Orthopedic · 41d
Cleared May 27, 2003
GENESIS II TOTAL KNEE SYSTEM
K030612 · MBH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared May 23, 2003
GMRS PRESS FIT STEMS WITH PUREFIX HA
K031217 · LZO
Howmedica Osteonics
Orthopedic · 36d
Cleared May 22, 2003
HLS UNI EVOLUTION PROSTHESIS
K022211 · HSX
Tornier
Orthopedic · 318d
Cleared May 22, 2003
SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM
K030623 · MBH
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared May 22, 2003
APEX MODULAR ACETABULAR CUP
K031110 · LPH
Apex Surgical, LLC
Orthopedic · 44d
Cleared May 22, 2003
TEXAS T - PLATE
K031334 · HRS
Biomet, Inc.
Orthopedic · 24d
Cleared May 22, 2003
CEMEX SYSTEM FAST
K031430 · LOD
Exactech, Inc.
Orthopedic · 16d
Cleared May 20, 2003
OSSATURA BCP BONE VOID FILLER
K030131 · MQV
Isotis NV
Orthopedic · 126d
Cleared May 20, 2003
CALLOS
K030554 · MQV
Skeletal Kinetics, LLC
Orthopedic · 88d
Cleared May 16, 2003
INTERPORE CROSS CEMENT RESTRICTOR
K023908 · JDK
Interpore Cross Intl.
Orthopedic · 172d
Cleared May 16, 2003
CD HORIZON SPINAL SYSTEM
K030932 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 52d
Cleared May 16, 2003
MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS
K031218 · JDB
Tornier
Orthopedic · 29d
Cleared May 15, 2003
MODIFICATION TO HORIZON SPINAL SYSTEM
K030840 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 59d
Cleared May 13, 2003
MODIFICATION TO EASYS TRANSVERSE CONNECTION
K031290 · MNH
Scient'X USA, Inc.
Orthopedic · 20d
Cleared May 06, 2003
SURGICAL SIMPLEX P WITH TOBRAMYCIN
K014199 · LOD
Howmedica Osteonics Corp.
Orthopedic · 501d
Cleared May 05, 2003
ADHOC CLAW
K023963 · MBI
Future Medical Systems, Inc.
Orthopedic · 157d
Cleared May 05, 2003
SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES
K031178 · HRS
Synthes (Usa)
Orthopedic · 21d
Cleared May 01, 2003
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES
K030733 · LPH
Zimmer, Inc.
Orthopedic · 52d
Cleared May 01, 2003
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
K031162 · JDQ
Smith & Nephew, Inc.
Orthopedic · 17d
Cleared Apr 28, 2003
ORTHOPEDIC WIRE
K031127 · JDR
Howmedica Osteonics Corp.
Orthopedic · 19d
Cleared Apr 24, 2003
AMATOMICAL SHOULDER WITH REMOVABLE HEAD
K030259 · KWS
Centerplus Orthopedics, Inc.
Orthopedic · 90d
Cleared Apr 24, 2003
IMPACT SUTURE ANCHOR. MODEL 433510
K030388 · HWC
Bionx Implants, Ltd.
Orthopedic · 78d
Cleared Apr 24, 2003
BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM
K030595 · KWQ
Blackstone Medical, Inc.
Orthopedic · 58d