Home / 510(k) Clearances / K210099

510(k) K210099

Meticuly Patient-Specific Titanium Mesh Implant by Meticuly Co., Ltd. — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2021
Date Received
January 14, 2021
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 Meticuly Co., Ltd.

  • K252958 — METICULY Patient-specific titanium mesh implant (January 14, 2026)
  • K232889 — METICULY Patient-specific titanium maxillofacial mesh implant (April 30, 2024)

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)
  • K212058 — Longeviti ClearFit™ OTS Cranial Implants (September 8, 2021)
  • K210616 — Longeviti PMMA Static Cranial Implant (March 31, 2021)
  • K203349 — Longeviti ClearFit Cranial Implant (December 16, 2020)