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
12385–12408 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 20, 2002
SYNTHES PILON PLATE
K020602 · HRS
Synthes
Orthopedic · 87d
Cleared May 20, 2002
MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K021025 · MQP
Implex Corp.
Orthopedic · 52d
Cleared May 16, 2002
MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER
K011726 · MQV
Millenium Biologix, Inc.
Orthopedic · 346d
Cleared May 16, 2002
APATIGHT-TCP BONE GRAFT SUBSTITUTE
K013966 · MQV
Cerabio, LLC
Orthopedic · 164d
Cleared May 16, 2002
APEX INTRAMEDULLARY NAIL SYSTEM
K020562 · HSB
Magly Orthopedics, LLC
Orthopedic · 85d
Cleared May 16, 2002
EBI AIS SPINE SYSTEM
K020887 · MQP
Ebi, L.P.
Orthopedic · 59d
Cleared May 16, 2002
EBI XFIX RAIL SYSTEM
K021031 · KTT
Ebi, L.P.
Orthopedic · 48d
Cleared May 14, 2002
MS-30 LATERAL FEMORAL STEM
K020713 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 70d
Cleared May 14, 2002
SL-PLUS LATERALIZED STEM
K021178 · JDI
Plus Orthopedics
Orthopedic · 29d
Cleared May 13, 2002
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
K020615 · MEH
Howmedica Osteonics Corp.
Orthopedic · 77d
Cleared May 13, 2002
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
K021182 · JDW
Biomet, Inc.
Orthopedic · 28d
Cleared May 13, 2002
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K021226 · KWQ
Medtronic Sofamor Danek
Orthopedic · 25d
Cleared May 09, 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K020709 · KWP
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared May 08, 2002
SYNTHES CALCANEAL PLATE
K020401 · HRS
Synthes (Usa)
Orthopedic · 90d
Cleared May 08, 2002
MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD
K021148 · MNH
Depuyacromed
Orthopedic · 28d
Cleared May 06, 2002
PRE-LOADED BIOSTINGER HORNET
K020377 · HWC
Linvatec Corp.
Orthopedic · 90d
Cleared May 06, 2002
EXPANDABLE KNEE
K020381 · KRO
Biomet Orthopedics, Inc.
Orthopedic · 90d
Cleared May 06, 2002
ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED
K020383 · JWH
Ortho Development Corp.
Orthopedic · 90d
Cleared May 06, 2002
T2 ARTHRODESIS NAIL SYSTEM
K020384 · HSB
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared May 03, 2002
SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
K012800 · HRY
Whiteside Biomechanics, Inc.
Orthopedic · 255d
Cleared May 03, 2002
MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM
K020554 · JWJ
Kinetikos Medical, Inc.
Orthopedic · 72d
Cleared May 03, 2002
EBI XFIX DFS SYSTEM
K021091 · KTT
Ebi, L.P.
Orthopedic · 29d
Cleared May 03, 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K021106 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared May 03, 2002
ESOP HA FEMORAL STEM
K021108 · MEH
Fournitures Hospitalieres
Orthopedic · 28d