Spinal Fixation System

Device Code: 4756

Product Code(s): PWG

Definition: Stabilization Of The Posterior Thoracic And Lumbar Spine

Device Classification Information

Device Type ID4756
Device NameSpinal Fixation System
Physical StateThe Spinal Rods And Connectors Are Made Of Titanium Alloy Per ASTM Standards.
Technical MethodThe Subject Spinal Rods And Connectors Attach To The Posterior Spine With Pedicle Screws And/ Or Hooks.
Target AreaPosterior Thoracic And Lumbar Spine
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Posterior Spine Devices Branch (PSDB)
Submission TypeContact ODE
FDA Device ClassificationClass Not Classified Medical Device
Product CodePWG
GMP ExemptNo
Summary MRIneligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4756
DeviceSpinal Fixation System
Product CodePWG
TPLC Last Update: 2019-04-02 20:55:09

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