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FDA 510(k), K051309, ROI FUSION RODS & PLATES
FDA 510(k), K051309, ROI FUSION RODS & PLATES
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510(K) Number: K051309
Device Name: ROI FUSION RODS & PLATES
Manufacturer: J.D. WEBB
Device Classification Name: Screw, Fixation, Bone
Regulation Number: HWC
Classification Product Code: 05/19/2005
Date Received: 07/11/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: ROI FUSION RODS & PLATES
Manufacturer: J.D. WEBB
Device Classification Name: Screw, Fixation, Bone
Regulation Number: HWC
Classification Product Code: 05/19/2005
Date Received: 07/11/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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