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
11881–11904 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 03, 2003
TIE-IN TRAPEZIUM
K033529 · KYI
Wrightmedicaltechnologyinc
Orthopedic · 23d
Cleared Dec 03, 2003
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K033635 · KTT
Ebi, L.P.
Orthopedic · 14d
Cleared Dec 02, 2003
CAP3 BONE SUBSTITUTE MATERIAL
K033138 · MQV
Etex Corp.
Orthopedic · 63d
Cleared Nov 28, 2003
TRIHA +
K031826 · MQV
Teknimed, S.A.
Orthopedic · 168d
Cleared Nov 28, 2003
MODIFICATION TO VERSABOND BONE CEMENT
K033509 · LOD
Smith & Nephew, Inc.
Orthopedic · 22d
Cleared Nov 26, 2003
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
K030319 · KWD
Wrightmedicaltechnologyinc
Orthopedic · 300d
Cleared Nov 26, 2003
CEMSTOP CEMENT RESTRICTOR
K032685 · LZN
Teknimed, S.A.
Orthopedic · 89d
Cleared Nov 26, 2003
SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH...
K033411 · KTT
Synthes (Usa)
Orthopedic · 30d
Cleared Nov 26, 2003
REFLECTION CONSTRAINED LINER
K033442 · KWZ
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Nov 20, 2003
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
K030958 · MNI
Ortho Tec, LLC
Orthopedic · 238d
Cleared Nov 20, 2003
SCORPIO NRG KNEE SYSTEM
K030978 · JWH
Howmedica Osteonics Corp.
Orthopedic · 237d
Cleared Nov 20, 2003
GROWTH GUIDANCE PLATE
K031493 · HRS
University of Utah/School of Medicine
Orthopedic · 192d
Cleared Nov 20, 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K032286 · MQV
Biomet Orthopedics, Inc.
Orthopedic · 119d
Cleared Nov 20, 2003
UCR SPINAL SYSTEM
K032739 · MNI
Seaspine
Orthopedic · 77d
Cleared Nov 20, 2003
BI-ANGULAR SHOULDER SYSTEM
K032895 · MBF
Biomet, Inc.
Orthopedic · 64d
Cleared Nov 19, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
K033384 · JDK
Implex Corp.
Orthopedic · 27d
Cleared Nov 18, 2003
DELTA SHOULDER
K021478 · PHX
Depuy, Inc.
Orthopedic · 559d
Cleared Nov 18, 2003
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
K031666 · HRS
Arthrex, Inc.
Orthopedic · 173d
Cleared Nov 14, 2003
CLICK'X MONOAXIAL SCREWS AND HOOKS
K031175 · KWP
Synthes (Usa)
Orthopedic · 214d
Cleared Nov 14, 2003
PASSMED SPINAL SYSTEM
K032094 · KWP
Medicrea
Orthopedic · 130d
Cleared Nov 14, 2003
DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS
K033329 · HSB
Depuy, Inc.
Orthopedic · 29d
Cleared Nov 13, 2003
NUVASIVE MESH
K032476 · MQP
Nuvasive, Inc.
Orthopedic · 93d
Cleared Nov 13, 2003
STELKAST UNICONDYLAR KNEE SYSTEM
K032824 · HSX
Stelkast Company
Orthopedic · 64d
Cleared Nov 13, 2003
EXACTECH 12/14 ALUMINA FEMORAL HEAD
K032964 · LPH
Exactech, Inc.
Orthopedic · 51d