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510(k) K240567

CustomizedBone Service by Fin-Ceramica Faenza S.P.A. — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2024
Date Received
February 29, 2024
Clearance Type
Special
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 Fin-Ceramica Faenza S.P.A.

  • K193547 — CustomizedBone Service (January 17, 2020)
  • K180513 — CustomizedBone Service (May 15, 2018)
  • K171507 — CustomizedBone Service (September 1, 2017)
  • K160707 — CustomizedBone Service (December 17, 2016)

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  • K210099 — Meticuly Patient-Specific Titanium Mesh Implant (December 21, 2021)
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  • K210616 — Longeviti PMMA Static Cranial Implant (March 31, 2021)
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