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510(k) K133082

OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE by Osteosymbionics, LLC — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2014
Date Received
September 30, 2013
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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  • K072601 — OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT (December 10, 2007)

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