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
10249–10272 of 17,816
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 25, 2007
VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS
K062666 · MQP
Ortho Development Corp.
Orthopedic · 140d
Cleared Jan 25, 2007
FEMORAL INTRAFIX SCREW AND SHEATH
K063577 · MBI
Johnson & Johnson Company
Orthopedic · 56d
Cleared Jan 25, 2007
PILOT SPINAL SYSTEM
K063601 · MNI
Life Spine
Orthopedic · 52d
Cleared Jan 25, 2007
MODIFICATION TO HIPSTAR FEMORAL STEM
K063822 · LPH
Stryker Orthopaedics
Orthopedic · 30d
Cleared Jan 24, 2007
ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY
K063251 · KWA
Zimmer, Inc.
Orthopedic · 89d
Cleared Jan 24, 2007
MODIFICATION TO EASYSPINE SYSTEM
K063794 · MNI
Ldr Spine USA
Orthopedic · 33d
Cleared Jan 23, 2007
INION CPS/OTPS FREEDOMPLATE
K063410 · HRS
Inion , Ltd.
Orthopedic · 71d
Cleared Jan 22, 2007
TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT
K063423 · JWH
Howmedica Osteonics
Orthopedic · 70d
Cleared Jan 22, 2007
MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE
K063487 · KTT
Merete Medical GmbH
Orthopedic · 66d
Cleared Jan 19, 2007
SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM
K062849 · HRX
Smith & Nephew, Inc.
Orthopedic · 116d
Cleared Jan 19, 2007
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG)
K062998 · KWA
Biomet Manufacturing Corp
Orthopedic · 109d
Cleared Jan 19, 2007
INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS
K063124 · MQV
Integra Lifesciences Corp.
Orthopedic · 98d
Cleared Jan 19, 2007
ACCIN UNI-KNEE SYSTEM
K063782 · HSX
Accin Corporation
Orthopedic · 29d
Cleared Jan 18, 2007
NUVASIVE ACP4 SYSTEM
K062590 · KWQ
Nuvasive, Inc.
Orthopedic · 139d
Cleared Jan 18, 2007
PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
K063211 · JWH
Stelkast Company
Orthopedic · 87d
Cleared Jan 18, 2007
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K063417 · NKB
Medtronic Sofamor Danek
Orthopedic · 66d
Cleared Jan 18, 2007
MICROPLASTY TIBIAL TRAYS
K063732 · JWH
Biomet Manufacturing Corp
Orthopedic · 31d
Cleared Jan 17, 2007
VSPSPN
K063438 · NDN
Tecres S.P.A.
Orthopedic · 64d
Cleared Jan 17, 2007
EXPEDIUM SPINE SYSTEM
K063741 · NKB
Depuy Spine, Inc.
Orthopedic · 30d
Cleared Jan 16, 2007
C-JAWS CERVICAL COMPRESSIVE MINI FRAME
K062181 · KWP
Medicrea Technologies
Orthopedic · 169d
Cleared Jan 16, 2007
EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM
K062775 · LPH
Ortho Development Corp.
Orthopedic · 120d
Cleared Jan 16, 2007
U2 HIP STEM, TI PLASMA SPRAY
K062978 · LWJ
United Orthopedic Corp.
Orthopedic · 109d
Cleared Jan 16, 2007
SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
K063688 · HWE
The Anspach Effort, Inc.
Orthopedic · 35d
Cleared Jan 12, 2007
VERTIFLEX SPINAL SCREW SYSTEM
K062670 · MNH
Vertiflex (Tm), Incorporated
Orthopedic · 127d