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
10705–10728 of 17,816
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 26, 2006
SIMPLEX P SPEEDSET BONE CEMENT
K053198 · LOD
Howmedica Osteonics Corp.
Orthopedic · 71d
Cleared Jan 26, 2006
ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS
K053338 · HWC
Arthrex, Inc.
Orthopedic · 56d
Cleared Jan 26, 2006
TRIATHLON TOTAL KNEE SYSTEM
K053514 · JWH
Stryker Orthopaedics
Orthopedic · 41d
Cleared Jan 26, 2006
OSTEOSET DBM PELLETS
K053642 · MBP
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Jan 26, 2006
KOBY SURGICAL INTERNAL FIXATION SYSTEM
K060026 · HWC
Koby Surgical
Orthopedic · 22d
Cleared Jan 26, 2006
NEXA COMPRESSION SCREW
K060071 · HWC
Nexa Orthopedics, Inc.
Orthopedic · 17d
Cleared Jan 25, 2006
OSSIMEND (TM) BONE GRAFT MATERIAL
K052812 · MQV
Collagen Matrix, Inc.
Orthopedic · 113d
Cleared Jan 25, 2006
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS
K053180 · NDN
Arthrocare Corp.
Orthopedic · 72d
Cleared Jan 25, 2006
ANATOMICAL SHOULDER INVERSE/REVERSE
K053274 · PHX
Zimmer GmbH
Orthopedic · 63d
Cleared Jan 20, 2006
MBCP
K051774 · MQV
Biomatlante
Orthopedic · 203d
Cleared Jan 20, 2006
ESKA-LIBUR HIP STEM
K053557 · LPH
Eska Implants GmbH & Co.
Orthopedic · 30d
Cleared Jan 19, 2006
DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS
K053292 · MQP
Scient'X USA, Inc.
Orthopedic · 55d
Cleared Jan 13, 2006
DBX STRIP
K042829 · MBP
Musculoskeletal Transplant Foundation
Orthopedic · 458d
Cleared Jan 13, 2006
ENDIUS ATAVI SYSTEM
K053267 · HRX
Endius, Inc.
Orthopedic · 51d
Cleared Jan 13, 2006
T-PIN
K053513 · JDW
Union Surgical, LLC
Orthopedic · 28d
Cleared Jan 13, 2006
SHORT CITATION FEMORAL STEM
K053528 · MEH
Stryker Orthopaedics
Orthopedic · 25d
Cleared Jan 13, 2006
PROFEMUR LX HIP STEM
K053588 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 21d
Cleared Jan 11, 2006
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
K053472 · KTT
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Jan 06, 2006
NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113,...
K052566 · MNI
Abbott Spine, Inc.
Orthopedic · 109d
Cleared Jan 06, 2006
SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT
K053445 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 25d
Cleared Jan 06, 2006
CD HORIZON SPINAL SYSTEM
K053474 · NKB
Medtronic Sofamor Danek
Orthopedic · 24d
Cleared Jan 05, 2006
CD HORIZON SPINAL SYSTEM
K053101 · NKB
Medtronic Sofamor Danek
Orthopedic · 62d
Cleared Jan 05, 2006
5TH METATARSAL FRACTURE SCREW
K053136 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 57d
Cleared Jan 05, 2006
REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT
K053299 · HRY
Biomet Manufacturing, Inc.
Orthopedic · 41d