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510(k) K121102

OSTEOSYMBIONICS PEEK CRANIAL IMPLANT by Osteosymbionics, LLC — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2012
Date Received
April 11, 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

Other clearances by Osteosymbionics, LLC

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  • K111069 — OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT (September 22, 2011)
  • K072601 — OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT (December 10, 2007)

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