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510(k) K072601

OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT by Osteosymbionics, LLC — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2007
Date Received
September 14, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methyl Methacrylate For Cranioplasty
Device Class
Class II
Regulation Number
882.5300
Review Panel
NE
Submission Type

Other clearances by Osteosymbionics, LLC

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  • K111069 — OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT (September 22, 2011)

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