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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / October 2025 / K250297

510(k) cleared

TECHFIT Patient-Specific Cranial System

Techfit Digital Surgery, Inc. · Oct 27, 2025 · K250297

FDA cleared the TECHFIT Patient-Specific Cranial System from Techfit Digital Surgery, Inc. on Oct 27, 2025 under K250297, a traditional 510(k). The device falls under product code GWO, Plate, Cranioplasty, Preformed, Alterable, regulated at 21 CFR 882.5320 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jan 31, 2025. The decision came 269 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Techfit Digital Surgery, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250297?

K250297 is the FDA 510(k) for TECHFIT Patient-Specific Cranial System, submitted by Techfit Digital Surgery, Inc.. FDA's decision date was Oct 27, 2025, under product code GWO (Plate, Cranioplasty, Preformed, Alterable).

Who makes the TECHFIT Patient-Specific Cranial System?

Techfit Digital Surgery, Inc., based in Daytona Beach, FL, is the applicant of record for K250297.

How long did the K250297 review take?

FDA received the submission on Jan 31, 2025 and issued its decision on Oct 27, 2025, 269 days later.

← All decisions in October 2025