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
11713–11736 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 03, 2004
CERAFORM BONE VOID FILLER
K040669 · MQV
Teknimed, S.A.
Orthopedic · 49d
Cleared Apr 30, 2004
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
K031687 · KTT
Vanguard Medical Concepts, Inc.
Orthopedic · 333d
Cleared Apr 30, 2004
QUANTUM CEMENT RESTRICTOR
K040276 · JDK
Quantum Orthopedics
Orthopedic · 85d
Cleared Apr 30, 2004
PANALOK LOOP ANCHOR
K040827 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 31d
Cleared Apr 29, 2004
VERSABOND AB BONE CEMENT
K022688 · LOD
Smith & Nephew, Inc.
Orthopedic · 625d
Cleared Apr 29, 2004
MS-30 FEMORAL STEM STANDARD AND LATERAL
K040803 · LZO
Zimmer, Inc.
Orthopedic · 31d
Cleared Apr 29, 2004
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K040833 · KTT
Ebi, L.P.
Orthopedic · 29d
Cleared Apr 27, 2004
CALCIGEN -NAP BONE VOID FILLER
K033611 · MQV
Biomet, Inc.
Orthopedic · 162d
Cleared Apr 22, 2004
VANGUARD PATELLA COMPONENTS
K040770 · JWH
Biomet Manufacturing, Inc.
Orthopedic · 28d
Cleared Apr 21, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K034056 · MNH
Medtronic Sofamor Danek
Orthopedic · 113d
Cleared Apr 16, 2004
CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY...
K032447 · HWC
Linvatec Biomaterials, Ltd.
Orthopedic · 252d
Cleared Apr 16, 2004
KATALYST RADIAL HEAD IMPLANT
K032806 · KWI
Kinetikos Medical, Inc.
Orthopedic · 220d
Cleared Apr 16, 2004
IM TOTAL FEMUR
K033871 · JDI
Biomet, Inc.
Orthopedic · 126d
Cleared Apr 16, 2004
REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM
K040261 · KWQ
Stryker Spine
Orthopedic · 72d
Cleared Apr 16, 2004
EBI ESL SPINE SPACER SYSTEM
K040482 · MQP
Ebi, L.P.
Orthopedic · 51d
Cleared Apr 14, 2004
ALTIUS OCT SYSTEM
K033961 · KWP
Interpore Cross Intl.
Orthopedic · 114d
Cleared Apr 14, 2004
SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS
K040331 · HWC
Smith & Nephew, Inc.
Orthopedic · 63d
Cleared Apr 12, 2004
ART ANTERIOR SPINAL SYSTEM
K033148 · KWQ
Advanced Medical Technologies AG
Orthopedic · 195d
Cleared Apr 12, 2004
NUVASIVE SPINAL SYSTEM
K033546 · MNH
Nuvasive, Inc.
Orthopedic · 152d
Cleared Apr 12, 2004
SCORPIO TOTAL KNEE SYSTEM
K033972 · MBH
Howmedica Osteonics Corp.
Orthopedic · 112d
Cleared Apr 12, 2004
SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM
K040336 · HSB
Synthes (Usa)
Orthopedic · 61d
Cleared Apr 12, 2004
CERAMIC TIPPED SKULL PIN
K040363 · LYT
The Jerome Group, Inc.
Orthopedic · 59d
Cleared Apr 12, 2004
LANX ANTERIOR CERVIAL PLATE SYSTEM
K040401 · KWQ
Lanx, LLC
Orthopedic · 55d
Cleared Apr 12, 2004
PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES
K040593 · HRS
Zimmer, Inc.
Orthopedic · 35d