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
11569–11592 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 07, 2004
GENEX BONE GRAFT SUBSTITUTE
K040600 · MQV
Biocomposites, Ltd.
Orthopedic · 60d
Cleared May 07, 2004
PANALOK RC LOOP ANCHOR
K041065 · JDR
Depuy Mitek
Orthopedic · 14d
Cleared May 06, 2004
DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND...
K033273 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 209d
Cleared May 06, 2004
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
K040225 · KWZ
Osteoimplant Technology, Inc.
Orthopedic · 94d
Cleared May 06, 2004
MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
K040397 · KWQ
Encore Medical, L.P.
Orthopedic · 79d
Cleared May 05, 2004
TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE
K040267 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared May 05, 2004
DEPUY PRESERVATION UNICONDYLAR TIBIA
K040268 · HRY
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared May 05, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K040536 · MQP
Medtronic Sofamor Danek
Orthopedic · 64d
Cleared May 03, 2004
EOVIA CALCIUM PHOSPHATE CERAMIC
K040514 · MQV
Ortho Tec, LLC
Orthopedic · 66d
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