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
8017–8040 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 22, 2011
AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES
K112455 · HRS
Howmedica Osteonics Corp., Dba...
Orthopedic · 28d
Cleared Sep 21, 2011
ODALYS PEDICLE SCREW SYSTEM
K111370 · MNH
Kalitec Direct, LLC
Orthopedic · 128d
Cleared Sep 21, 2011
ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD
K111936 · LZO
Ortho Development
Orthopedic · 75d
Cleared Sep 20, 2011
Spacer-G and Spacer-K
K101356 · KWL
Tecres S.P.A.
Orthopedic · 494d
Cleared Sep 16, 2011
TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET...
K111629 · PHX
Encore Medical, L.P.
Orthopedic · 95d
Cleared Sep 16, 2011
JOURNEY II BCS KNEE SYSTEM
K111711 · JWH
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Sep 15, 2011
CD HORIZON SPINAL SYSTEM
K111457 · NKB
Medtronic Sofamor Danek
Orthopedic · 112d
Cleared Sep 15, 2011
CD HORIZON SPINAL SYSTEM
K111510 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 106d
Cleared Sep 15, 2011
SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM
K112025 · KWP
Spinal USA
Orthopedic · 62d
Cleared Sep 13, 2011
MEDICAL CONCEPTS INTERBODY FUSION SYSTEM
K110659 · MAX
Medical Concepts, Inc.
Orthopedic · 190d
Cleared Sep 13, 2011
CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM
K111115 · MNI
Captiva Spine, Inc.
Orthopedic · 145d
Cleared Sep 12, 2011
DISCOVERY
K111484 · ODP
Intuitive Spine, LLC
Orthopedic · 104d
Cleared Sep 09, 2011
IFS PROFILE PLATES, SCREWS, AND WASHERS
K110086 · HRS
Internal Fixation Systems, Inc.
Orthopedic · 240d
Cleared Sep 09, 2011
ENDOSKELETON(R) TAS
K111626 · OVD
Titan Spine, LLC
Orthopedic · 91d
Cleared Sep 09, 2011
SMITH & NEPHEW RJ CONSTRAINED LINERS
K111635 · KWZ
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Sep 08, 2011
A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
K111166 · MAX
Spineworks, LLC
Orthopedic · 135d
Cleared Sep 07, 2011
PILOT SPINAL SYSTEM
K111729 · NKB
Life Spine, Inc.
Orthopedic · 79d
Cleared Sep 06, 2011
HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR,...
K111472 · LPH
Tgm Medical
Orthopedic · 102d
Cleared Sep 02, 2011
BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION
K110791 · KWT
Zimmer, Inc.
Orthopedic · 165d
Cleared Sep 02, 2011
MICROSUTURE ANCHORS
K112237 · HWC
Arthrex, Inc.
Orthopedic · 29d
Cleared Aug 31, 2011
CMC CABLE FIX
K111032 · HTN
Instratek, Inc.
Orthopedic · 140d
Cleared Aug 31, 2011
CAPSURE(R) PS SYSTEM
K111913 · MNI
Spine Wave, Inc.
Orthopedic · 56d
Cleared Aug 30, 2011
DEPUY STTUNE (TM) PS KNEE SYSTEM
K111433 · OIY
DePuy Orthopaedics, Inc.
Orthopedic · 99d
Cleared Aug 30, 2011
TSRH SPINAL SYSTEMS
K111942 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 53d