Deroyal Spine Spacer System

by Deroyal Industries, Inc.

510(k) K131292

Deroyal Spine Spacer System is a Class II device made by Deroyal Industries, Inc., cleared under FDA 510(k) K131292 on 3 Feb 2014, 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) K131292↗

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	NumberK131292	Date3 Feb 2014Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K131292

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K131292
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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