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510(k) K180064

OsteoFab Patient Specific Cranial Device by Oxford Performance Materials, Inc. — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2018
Date Received
January 9, 2018
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

Other clearances by Oxford Performance Materials, Inc.

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  • K161052 — OsteoFab Patient Specific Facial Device (July 20, 2016)
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  • K133809 — OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE (July 28, 2014)
  • K121818 — OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE (February 7, 2013)

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