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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, Alterable
510(k) Number K250297
Device Name TECHFIT Patient-Specific Cranial System
Applicant
Techfit Digital Surgery, Inc.
1511 Aviation Center Pkwy.
Suite 220h
Daytona Beach,  FL  32114
Applicant Contact Angela Lema
Correspondent
Techfit Digital Surgery, Inc.
1511 Aviation Center Pkwy.
Suite 220h
Daytona Beach,  FL  32114
Correspondent Contact Angela Lema
Regulation Number882.5320
Classification Product Code
GWO  
Date Received01/31/2025
Decision Date 10/27/2025
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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