510(k) K250297

TECHFIT Patient-Specific Cranial System by Techfit Digital Surgery, Inc. — Product Code GWO

K250297 is an FDA 510(k) premarket notification submitted by Techfit Digital Surgery, Inc. for the device "TECHFIT Patient-Specific Cranial System". The FDA issued a decision of Substantially Equivalent on October 27, 2025. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. Techfit Digital Surgery, Inc. has at least 4 other 510(k) clearances on record.