FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
12313–12336 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared May 02, 2002
RPX TITANIUM CEMNT RESTRICTOR
K020344 · JDK
Sulzer Spine-Tech
Orthopedic · 90d
Cleared May 01, 2002
FIXATION (STEINMANN) PINS
K013888 · HTY
Miltex, Inc.
Orthopedic · 159d
Cleared Apr 29, 2002
CLEARVIEW WRIST FIXATOR
K020311 · KTT
Rigid FX Orthopedics, Incorporated
Orthopedic · 90d
Cleared Apr 26, 2002
SUPER EON PLUS FEMORAL STEMS
K020989 · JDI
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Apr 25, 2002
S2 FEMORAL NAIL
K021026 · HSB
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 25, 2002
S2 TIBIAL NAIL
K021027 · HSB
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 22, 2002
SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP)
K020244 · KWQ
Synthes Spine
Orthopedic · 88d
Cleared Apr 22, 2002
DISTAL RADIUS PLATING SYSTEM
K020819 · HRS
Biomet, Inc.
Orthopedic · 40d
Cleared Apr 16, 2002
SYNTHES VERTEBRAL SPACER TI
K020152 · MQP
Synthes (Usa)
Orthopedic · 89d
Cleared Apr 16, 2002
TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM
K020963 · MEH
Biomet Orthopedics, Inc.
Orthopedic · 22d
Cleared Apr 15, 2002
SPIRAL RADIUS 90-D RODDING SYSTEM
K020134 · KWP
United States Surgical, A Division of...
Orthopedic · 90d
Cleared Apr 15, 2002
ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM
K020145 · LPH
Orthopaedic Innovations, Inc.
Orthopedic · 89d