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3D MAC Titanium Cranial Plate (TCP) System

by The Surgeon General, Department of the Army (TSG-DA) 510(k)

Active United States

510(k) K253116

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK253116 Date18 Jun 2026ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GXN
Device Class
Class II
Regulation
21 CFR Part 882.5330
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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