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FDA 510(k), K111166, A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
FDA 510(k), K111166, A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
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510(K) Number: K111166
Device Name: A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
Manufacturer: SPINEWORKS, LLC
Device Classification Name: Intervertebral Fusion Device With Bone Graft, Lumbar
Regulation Number: 888.3080
Classification Product Code: MAX
Date Received: 04/26/2011
Decision Date: 09/08/2011
Regulation Medical Specialty: Orthopedic
Device Name: A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
Manufacturer: SPINEWORKS, LLC
Device Classification Name: Intervertebral Fusion Device With Bone Graft, Lumbar
Regulation Number: 888.3080
Classification Product Code: MAX
Date Received: 04/26/2011
Decision Date: 09/08/2011
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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