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
13153–13176 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 16, 2000
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES...
K000242 · MEH
Exactech, Inc.
Orthopedic · 20d
Cleared Feb 16, 2000
IMPACT MODULAR TOTAL HIP SYSTEM
K000334 · LPH
Biomet, Inc.
Orthopedic · 13d
Cleared Feb 16, 2000
MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM
K994425 · HRX
Endius, Inc.
Orthopedic · 48d
Cleared Feb 15, 2000
PLR SPLINED REVISION STEM
K994184 · LZO
Biomet, Inc.
Orthopedic · 67d
Cleared Feb 14, 2000
WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013
K993903 · JDQ
Whiteside Biomechanics, Inc.
Orthopedic · 90d
Cleared Feb 14, 2000
LOCON-T DISTAL RADIAL PLATE
K994061 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 75d
Cleared Feb 11, 2000
EXETER CERAMIC FEMORAL HEADS
K993889 · LZO
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Feb 08, 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K000094 · MNH
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 26d
Cleared Feb 08, 2000
ARTHRO-SURGIMAT-A103
K000153 · HRX
W.O.M. World of Medicine GmbH
Orthopedic · 21d
Cleared Feb 08, 2000
CLICK'X
K992739 · MNH
Synthes Spine
Orthopedic · 176d
Cleared Feb 07, 2000
PAR 5 ACETABULAR COMPONENT
K000254 · JDI
Biomet, Inc.
Orthopedic · 10d
Cleared Feb 07, 2000
THE MARGRON HIP REPLACEMENT SYSTEM
K992815 · MEH
Portland Orthopaedics Pty. , Ltd.
Orthopedic · 171d
Cleared Feb 04, 2000
POROCOAT PRODIGY HIP PROSTHESIS
K000207 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 11d
Cleared Feb 04, 2000
WILTSE SYSTEM
K992012 · KWQ
Advanced Spine Fixation Systems, Inc.
Orthopedic · 234d
Cleared Feb 04, 2000
ACUMED MODULAR SHOULDER SYSTEM
K992525 · HSD
Acu Med, Inc.
Orthopedic · 191d
Cleared Feb 04, 2000
I.CO.S SCREW
K993762 · HWC
New Deal, S.A.
Orthopedic · 88d
Cleared Feb 04, 2000
ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH...
K993943 · MEH
Encore Orthopedics, Inc.
Orthopedic · 77d
Cleared Feb 04, 2000
MALLORY/HEAD SMOOTH FEMORAL COMPONENT
K994007 · JDI
Biomet, Inc.
Orthopedic · 72d
Cleared Feb 04, 2000
DOGBONE ACFS
K994383 · KWQ
Theken Surgical
Orthopedic · 38d
Cleared Feb 03, 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K000020 · MNH
Encore Orthopedics, Inc.
Orthopedic · 30d
Cleared Feb 03, 2000
EBI XFIX DFS RAIL SYSTEM
K000083 · KTT
Ebi, L.P.
Orthopedic · 22d
Cleared Feb 03, 2000
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
K000089 · HWC
Synthes (Usa)
Orthopedic · 22d
Cleared Feb 03, 2000
DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
K000172 · HRY
DePuy Orthopaedics, Inc.
Orthopedic · 14d
Cleared Feb 03, 2000
CD HORIZON SPINAL SYSTEM
K993810 · MNH
Danek Medical, Inc.
Orthopedic · 85d