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
11305–11328 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 19, 2004
SMITH & NEPHEW MODULAR HIP
K042127 · MEH
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Nov 19, 2004
VENTURE ANTERIOR CERVICAL PLATING SYSTEM
K042922 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Nov 19, 2004
DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H
K042966 · MAI
Linvatec Biomaterials, Ltd.
Orthopedic · 22d
Cleared Nov 18, 2004
CD HORIZON SPINAL SYSTEM
K042886 · NKB
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Nov 17, 2004
ALUMINA HEAD
K042035 · LZO
Fournitures Hospitalieres Industrie
Orthopedic · 111d
Cleared Nov 17, 2004
WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES
K042761 · KTT
Zimmer, Inc.
Orthopedic · 43d
Cleared Nov 17, 2004
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
K042986 · GXR
Synthes (Usa)
Orthopedic · 19d
Cleared Nov 16, 2004
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
K041443 · LZO
Osteoimplant Technology, Inc.
Orthopedic · 168d
Cleared Nov 16, 2004
ORTHOFIX VOLAR DISTAL RADIAL PLATE
K042766 · HRS
Orthofix, Inc.
Orthopedic · 42d
Cleared Nov 16, 2004
SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES
K042895 · KTT
Synthes (Usa)
Orthopedic · 27d
Cleared Nov 13, 2004
ASCENSION PYROSPHERE (PCS)
K042690 · KYI
Ascension Orthopedics, Inc.
Orthopedic · 45d
Cleared Nov 12, 2004
TOE MP JOINT, MODELS 10412-10414, 14958, 14960,...
K041595 · KWD
Biopro, Inc.
Orthopedic · 151d
Cleared Nov 12, 2004
OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE
K042914 · MBI
Opus Medical, Inc.
Orthopedic · 22d
Cleared Nov 09, 2004
SPIRALOK ANCHOR
K041069 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 197d
Cleared Nov 09, 2004
FASTIN RC ANCHOR
K041075 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 197d
Cleared Nov 09, 2004
SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS
K041170 · LZO
Howmedica Osteonics Corp.
Orthopedic · 189d
Cleared Nov 09, 2004
X-SERIES INTEGRAL RPP FEMORAL COMPONENTS
K042029 · LPH
Biomet, Inc.
Orthopedic · 104d
Cleared Nov 09, 2004
NOVATION 12/14 PRESS-FIT FEMORAL STEM
K042842 · LZO
Exactech, Inc.
Orthopedic · 26d
Cleared Nov 05, 2004
ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE
K042796 · HWC
Coapt Systems, Inc.
Orthopedic · 29d
Cleared Nov 04, 2004
METAL/METAL HIP SYSTEM
K040354 · KWA
Encore Medical, L.P.
Orthopedic · 266d
Cleared Nov 04, 2004
ARTHREX TRIMIT FAMILY
K041189 · HWC
Arthrex, Inc.
Orthopedic · 182d
Cleared Nov 04, 2004
ARTHREX TENODESIS SCREW FAMILY
K041356 · HWC
Arthrex, Inc.
Orthopedic · 168d
Cleared Nov 04, 2004
MSD SILO SPINAL SYSTEM
K042210 · MNI
Medtronic Sofamor Danek
Orthopedic · 80d
Cleared Nov 04, 2004
ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
K042337 · LPH
Zimmer, Inc.
Orthopedic · 66d