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510(k) K243715

Synthes Patient Specific Implants by Synthes GmbH — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2025
Date Received
December 2, 2024
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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  • K122455 — SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM (April 11, 2013)
  • K122647 — SYNTHES PATIENT SPECIFIC PLATE (February 28, 2013)

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