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
5497–5520 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 06, 2016
Piccolo Composite® Nailing System
K153536 · HSB
CarboFix Orthopedics , Ltd.
Orthopedic · 27d
Cleared Jan 06, 2016
Galaxy UNYCO System
K153233 · KTT
Orthofix Srl
Orthopedic · 58d
Cleared Jan 06, 2016
KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
K152604 · PML
Medtronic Sofamor Danek USA,...
Orthopedic · 117d
Cleared Jan 06, 2016
Amendia Interbody Fusion Devices
K151310 · MAX
Amendia, Inc.
Orthopedic · 233d
Cleared Jan 04, 2016
ROSA Spine
K151511 · OLO
Medtech S.A
Orthopedic · 214d
Cleared Dec 31, 2015
Internal Joint Stabilizer - Elbow
K153208 · OZI
Skeletal Dynamics, LLC
Orthopedic · 56d
Cleared Dec 30, 2015
CD HORIZON Spinal System, IPC POWEREASE System
K153463 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Dec 30, 2015
Arsenal Spinal Fixation System
K152968 · NKB
Alphatec Spine, Inc.
Orthopedic · 83d
Cleared Dec 30, 2015
Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm...
K151907 · KTT
Zimmer, Inc.
Orthopedic · 170d
Cleared Dec 30, 2015
Bio2 Fusion Implant System
K151876 · HTY
Bio2 Technologies, Inc.
Orthopedic · 174d
Cleared Dec 28, 2015
Asnis JFX System
K153154 · HWC
Stryker Trauma AG
Orthopedic · 56d
Cleared Dec 28, 2015
PediatrOS RigidTack/FlexTack
K151762 · JDR
Merete Medical GmbH
Orthopedic · 182d
Cleared Dec 28, 2015
Intellijoint HIP(tm) System
K151364 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 221d
Cleared Dec 23, 2015
INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
K152047 · KWS
Ascension Orthopedics
Orthopedic · 153d
Cleared Dec 22, 2015
Rectangular Corpectomy Cage
K152460 · MQP
Amendia, Inc.
Orthopedic · 116d
Cleared Dec 22, 2015
PRECICE Trauma Nail System
K152370 · HSB
Ellipse Technologies, Incorporated
Orthopedic · 123d
Cleared Dec 21, 2015
Apex Revision Knee System
K153437 · JWH
Omnilife Science
Orthopedic · 24d
Cleared Dec 21, 2015
Monster BITE Screw System
K153378 · HWC
Paragon 28
Orthopedic · 28d
Cleared Dec 21, 2015
FastFrame External Fixation System-Ankle Spanning
K152755 · KTT
Zimmer, Inc.
Orthopedic · 88d
Cleared Dec 21, 2015
AXI+LINE Proximal Bunion Correction System
K152548 · HRS
Nextremity Solutions, Inc.
Orthopedic · 104d
Cleared Dec 21, 2015
OsteoMed ExtremiLOCK Wrist Plating System
K152145 · HRS
Osteomed
Orthopedic · 140d
Cleared Dec 21, 2015
Sahara Stabilization System
K151481 · OVD
K2m, Inc.
Orthopedic · 202d
Cleared Dec 18, 2015
AERO -C Cervical Cage System
K152532 · ODP
Stryker Spine
Orthopedic · 106d
Cleared Dec 18, 2015
TOMCAT Cervical Spinal System
K152515 · OVE
Choicespine, LP
Orthopedic · 107d