Home / 510(k) Clearances / K232889

510(k) K232889

METICULY Patient-specific titanium maxillofacial mesh implant by Meticuly Co., Ltd. — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2024
Date Received
September 18, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

Other clearances by Meticuly Co., Ltd.

  • K252958 — METICULY Patient-specific titanium mesh implant (January 14, 2026)
  • K210099 — Meticuly Patient-Specific Titanium Mesh Implant (December 21, 2021)

Other clearances for product code JEY

  • K253373 — Southern Craniomaxillofacial (CMF) System (December 19, 2025)
  • K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsor (November 7, 2025)
  • K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled) (August 16, 2024)
  • K240651 — MRI Universal (July 12, 2024)
  • K233874 — tmCMF Solution (July 11, 2024)
  • K232350 — Stryker Facial iD System (January 13, 2024)
  • K230398 — MedCAD® AccuPlate® 3DTi Patient-Specific Plating System (September 26, 2023)
  • K230733 — Stryker Resorbable Fixation System (August 5, 2023)
  • K222650 — Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate (December 9, 2022)
  • K220360 — Tandry CMF Plate System (November 10, 2022)