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FDA 510(k), K072601, OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
FDA 510(k), K072601, OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
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510(K) Number: K072601
Device Name: OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
Manufacturer: OSTEOSYMBIONICS, LLC
Device Classification Name: methyl methacrylate for cranioplasty
Regulation Number: 882.5300
Classification Product Code: GXP
Date Received: 09/14/2007
Decision Date: 12/10/2007
Regulation Medical Specialty: Neurology
Device Name: OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
Manufacturer: OSTEOSYMBIONICS, LLC
Device Classification Name: methyl methacrylate for cranioplasty
Regulation Number: 882.5300
Classification Product Code: GXP
Date Received: 09/14/2007
Decision Date: 12/10/2007
Regulation Medical Specialty: Neurology
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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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