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
13177–13200 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 11, 2000
MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS...
K990830 · LPH
Biomet, Inc.
Orthopedic · 396d
Cleared Apr 10, 2000
HEMISPHERE MODULAR CUP SYSTEM
K000321 · LPH
Ortho Development Corp.
Orthopedic · 68d
Cleared Apr 10, 2000
5.0MM SPINAL SCREWS
K994288 · MNH
Ortho Tec, LLC
Orthopedic · 112d
Cleared Apr 06, 2000
PEDIATRIC FIXATION RODS
K000764 · JDS
Biomet, Inc.
Orthopedic · 28d
Cleared Apr 06, 2000
OSTEONICS SERIES 7000 AD TIBIAL TRAY
K983657 · HRY
Osteonics Corp.
Orthopedic · 535d
Cleared Apr 06, 2000
BICON-PLUS ACETABULAR COMPONENTS
K992154 · LPH
Plus Orthopedics
Orthopedic · 286d
Cleared Apr 06, 2000
ESKA MODULAR HIP SYSTEM
K993027 · LPH
Specs USA, Inc.
Orthopedic · 210d
Cleared Apr 04, 2000
PROVEN KNEE SYSTEM
K000113 · JWH
Stelkast Company
Orthopedic · 81d
Cleared Apr 03, 2000
ASNIS III CANNULATED SCREW SYSTEM
K000080 · HWC
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Apr 03, 2000
BOHN FEMORAL COMPONENT
K000262 · MEH
Biomet Manufacturing, Inc.
Orthopedic · 66d
Cleared Apr 03, 2000
OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01
K000797 · JDR
Orthopaedic Biosystems, Ltd.
Orthopedic · 21d
Cleared Mar 30, 2000
KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)
K000046 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 83d
Cleared Mar 30, 2000
COLORADO II SPINAL SYSTEM
K984360 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 479d
Cleared Mar 29, 2000
SINGLE SIZE TENDON SPACER
K000019 · HXA
Medist International
Orthopedic · 85d
Cleared Mar 29, 2000
SYNTHES ANTERIOR CSLP SYSTEM
K000742 · KWQ
Synthes Spine
Orthopedic · 22d
Cleared Mar 24, 2000
ORTHO DEVELOPMENT BALANCED KNEE SYSTEM
K994370 · JWH
Ortho Development Corp.
Orthopedic · 88d
Cleared Mar 23, 2000
PINNACLE ACETABULAR SYSTEM
K000306 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 51d
Cleared Mar 23, 2000
SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828
K000616 · MAI
Bionx Implants, Ltd.
Orthopedic · 28d
Cleared Mar 16, 2000
TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
K994366 · MEH
Howmedica Osteonics Corp.
Orthopedic · 80d
Cleared Mar 15, 2000
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
K000066 · HRS
Synthes (Usa)
Orthopedic · 65d
Cleared Mar 15, 2000
SYNTHES ANTERIOR CSLP SYSTEM
K000536 · KWQ
Synthes Spine
Orthopedic · 28d
Cleared Mar 15, 2000
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
K000538 · LPH
Biomet, Inc.
Orthopedic · 27d
Cleared Mar 15, 2000
CENTAUR SPINAL SYSTEM
K994347 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Mar 15, 2000
SYNTHES BUTTON PLATE
K994364 · MBI
Synthes (Usa)
Orthopedic · 79d