510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253116Substantially Equivalent

3D MAC Titanium Cranial Plate (TCP) System

The Surgeon General, Department of the Army (TSG-DA), Fort Detrick MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253116 is the FDA 510(k) clearance record for 3D MAC Titanium Cranial Plate (TCP) System, a class II device, cleared for The Surgeon General, Department of the Army (TSG-DA) on under FDA product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable). FDA records list 2 510(k) clearances for The Surgeon General, Department of the Army (TSG-DA), from to . As of , FDA records show no recalls naming K253116.

Clearance record

Decision date
Received
(267 days to decision)
Product code
GXN Plate, Cranioplasty, Preformed, Non-Alterable
Regulation
21 CFR 882.5330
Device class
Class II
Review panel
Neurology
Applicant
The Surgeon General, Department of the Army (TSG-DA) Dha R&D - Medical Research And Development Command; Attn:, Fort Detrick MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXN

Trailing 12 months
6 clearances under product code GXN in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GXN, trailing twelve months
MonthClearances
November 20252
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260