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Vantage Lumbar Decompression Kit

by Surgentec LLC

510(k) K263208

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 1 Nov 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 1 Nov 2026. What this means

Regulatory status

as of registry sync 1 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK263208 Date14 Oct 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 1 Nov 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HRX
FDA applicant
SurGenTec, LLC
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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