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
6001–6024 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 20, 2015
IntelliSense Drill
K143191 · HWE
Mcginley Innovations
Orthopedic · 106d
Cleared Feb 20, 2015
NuVasive X-CORE(R) Expandable VBR System
K142205 · MQP
Nuvasive, Inc.
Orthopedic · 193d
Cleared Feb 20, 2015
EASY OUT
K141401 · HWC
Feet For Life Podiatry Center
Orthopedic · 268d
Cleared Feb 20, 2015
CARRICELL
K132868 · MQV
Etex Corporation
Orthopedic · 525d
Cleared Feb 19, 2015
LYNC intramedullary implant
K143049 · HTY
Novastep
Orthopedic · 119d
Cleared Feb 19, 2015
StaXx(R) XD System
K142996 · MQP
Spine Wave, Inc.
Orthopedic · 126d
Cleared Feb 19, 2015
SYPHER SPACER SYSTEM
K141798 · OVD
Biogennix, LLC
Orthopedic · 231d
Cleared Feb 17, 2015
Klassic Knee System-Sombrero Patella
K150105 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 28d
Cleared Feb 17, 2015
NUROS BONE GRAFT SUBSTITUTE
K140913 · MQV
Oriental Resources Development Limited
Orthopedic · 313d
Cleared Feb 13, 2015
CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
K143375 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 80d
Cleared Feb 13, 2015
DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS
K140881 · MBH
Depuy(Ireland)
Orthopedic · 312d
Cleared Feb 12, 2015
Navigated Vertex Select Instruments
K143628 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 52d
Cleared Feb 12, 2015
CD HORIZON Spinal System
K143569 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 58d
Cleared Feb 12, 2015
PedFuse Pedicle Screw System
K143377 · MNH
Spinefrontier, Inc.
Orthopedic · 79d
Cleared Feb 12, 2015
Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical...
K143297 · MAX
Zimmer Spine, Inc.
Orthopedic · 87d
Cleared Feb 12, 2015
Visionaire Disposable Instruments
K143226 · JWH
Smith & Nephew, Inc.
Orthopedic · 94d
Cleared Feb 12, 2015
Vanguard 360 Revision Knee System
K143192 · JWH
Biomet, Inc.
Orthopedic · 98d
Cleared Feb 12, 2015
NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM
K141222 · NKB
Life Spine, Inc.
Orthopedic · 276d
Cleared Feb 12, 2015
PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT
K140900 · KRO
Stanmore Worldwide Implants , Ltd.
Orthopedic · 310d
Cleared Feb 11, 2015
CD HORIZON SPINAL SYSTEM
K150178 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 16d
Cleared Feb 11, 2015
Tensyn Plug
K143092 · HTN
Dallen Medical, Inc.
Orthopedic · 106d
Cleared Feb 10, 2015
STERISPINE PS Pedicle Screw
K150092 · NKB
Safe Orthopaedics
Orthopedic · 25d
Cleared Feb 10, 2015
MICRONAIL Distal Radius System
K150073 · HSB
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Feb 10, 2015
PASS LP Spinal System
K150049 · MNI
Medicrea International
Orthopedic · 29d