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FDA 510(k), K112595, COFLEX-F
FDA 510(k), K112595, COFLEX-F
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510(K) Number: K112595
Device Name: COFLEX-F
Manufacturer: PARADIGM SPINE, LLC
Device Classification Name: Appliance, Fixation, Spinal Interlaminal
Regulation Number: 888.3050
Classification Product Code: KWP
Date Received: 09/07/2011
Decision Date: 02/13/2012
Regulation Medical Specialty: Orthopedic
Device Name: COFLEX-F
Manufacturer: PARADIGM SPINE, LLC
Device Classification Name: Appliance, Fixation, Spinal Interlaminal
Regulation Number: 888.3050
Classification Product Code: KWP
Date Received: 09/07/2011
Decision Date: 02/13/2012
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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