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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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