Steerable Plateau Ti

by Life Spine, Inc.

510(k) K193521

Steerable Plateau Ti is a Class II device made by Life Spine, Inc., cleared under FDA 510(k) K193521 on 6 Feb 2020, active as of 22 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 22 Oct 2026

Documents

510(k) K193521↗

FDA record

Trust

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK193521	Date6 Feb 2020Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K193521

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K193521
FDA product code: MAX

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

Other devices from Life Spine, Inc.

Arx 13-5550-13

Class II
Arx 13-6540-13

Class II
Arx 13-6550-13

Class II
Arx 13-5545-13

Class II

See all devices from Life Spine, Inc. →