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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 / September 2025 / K252054

510(k) cleared

SpineAR SNAP (SyncAR Spine)

Surgical Theater, Inc. · Sep 29, 2025 · K252054

FDA cleared the SpineAR SNAP (SyncAR Spine) from Surgical Theater, Inc. on Sep 29, 2025 under K252054, a traditional 510(k). The device falls under product code SBF, Orthopedic Augmented Reality, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jul 1, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Surgical Theater, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252054?

K252054 is the FDA 510(k) for SpineAR SNAP (SyncAR Spine), submitted by Surgical Theater, Inc.. FDA's decision date was Sep 29, 2025, under product code SBF (Orthopedic Augmented Reality).

Who makes the SpineAR SNAP (SyncAR Spine)?

Surgical Theater, Inc., based in Beachwood, OH, is the applicant of record for K252054.

How long did the K252054 review take?

FDA received the submission on Jul 1, 2025 and issued its decision on Sep 29, 2025, 90 days later.

← All decisions in September 2025