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510(k) K121818

OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE by Oxford Performance Materials — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2013
Date Received
June 20, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Device Class
Class II
Regulation Number
882.5330
Review Panel
NE
Submission Type

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  • K133809 — OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE (July 28, 2014)

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