Home / 510(k) Clearances / K160707

510(k) K160707

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2016
Date Received
March 14, 2016
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 Fin-Ceramica Faenza S.P.A.

  • K240567 — CustomizedBone Service (March 28, 2024)
  • K193547 — CustomizedBone Service (January 17, 2020)
  • K180513 — CustomizedBone Service (May 15, 2018)
  • K171507 — CustomizedBone Service (September 1, 2017)

Other clearances for product code GXN

  • K252958 — METICULY Patient-specific titanium mesh implant (January 14, 2026)
  • K243715 — Synthes Patient Specific Implants (November 12, 2025)
  • K252573 — KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosyn (November 10, 2025)
  • K240567 — CustomizedBone Service (March 28, 2024)
  • K231920 — Longeviti ClearFit OTS Cranial Implant (November 9, 2023)
  • K214109 — PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) (October 28, 2022)
  • K220357 — MedCAD AccuShape Titanium Patient-Specific Cranial Implant (August 26, 2022)
  • K210099 — Meticuly Patient-Specific Titanium Mesh Implant (December 21, 2021)
  • K212058 — Longeviti ClearFit™ OTS Cranial Implants (September 8, 2021)
  • K210616 — Longeviti PMMA Static Cranial Implant (March 31, 2021)