Life Spine Resolute™ Threaded Cage System

by Life Spine, Inc.

510(k) K181625

Life Spine Resolute™ Threaded Cage System is a Class II device made by Life Spine, Inc., cleared under FDA 510(k) K181625 on 11 Dec 2018, active as of 26 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

510(k) K181625↗

FDA record

Trust

Source FDA 510(k), synced 26 Oct 2026.

Regulatory status

as of registry sync 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK181625	Date11 Dec 2018Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K181625

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K181625
FDA product code: MAX

Device class: Class II
Regulation: 21 CFR Part 888.3080
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

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