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The Tracker / October 2026 / K263208

510(k) cleared

Vantage Lumbar Decompression Kit

SurGenTec, LLC · Oct 14, 2026 · K263208

FDA cleared the Vantage Lumbar Decompression Kit from SurGenTec, LLC on Oct 14, 2026 under K263208, a special 510(k). The device falls under product code HRX, Arthroscope, regulated at 21 CFR 888.1100 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 14, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

SurGenTec, LLC has 8 other decisions in the tracker over the last 12 months: K252995 (Durashield Device Kit), K262581 (GraftGun Universal Graft Delivery System (GDS®)), K261381 (TiLink-L SI Joint Fusion System), K262121 (Ion-L Navigated Instruments).

Questions & Answers

What did FDA clear under K263208?

K263208 is the FDA 510(k) for Vantage Lumbar Decompression Kit, submitted by SurGenTec, LLC. FDA's decision date was Oct 14, 2026, under product code HRX (Arthroscope).

Who makes the Vantage Lumbar Decompression Kit?

SurGenTec, LLC, based in Boca Raton, FL, is the applicant of record for K263208.

How long did the K263208 review take?

FDA received the submission on Sep 14, 2026 and issued its decision on Oct 14, 2026, 30 days later.

← All decisions in October 2026