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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Non-Alterable
510(k) Number K253116
Device Name 3D MAC Titanium Cranial Plate (TCP) System
Applicant
The Surgeon General, Department of the Army (TSG-DA)
Dha R&D - Medical Research And Development Command; Attn:
Fcmr-Ora, 1541 Porter St.
Fort Detrick,  MD  21702
Applicant Contact Emily Badraslioglu
Correspondent
The Surgeon General, Department of the Army (TSG-DA)
Dha R&D - Medical Research And Development Command; Attn:
Fcmr-Ora, 1541 Porter St.
Fort Detrick,  MD  21702
Correspondent Contact India El
Regulation Number882.5330
Classification Product Code
GXN  
Subsequent Product Code
GWO  
Date Received09/24/2025
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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