Aequalis PerFORM+ Shoulder System

by Tornier, Inc. 2 variants

510(k) K160975

Aequalis PerFORM+ Shoulder System is a Class II device made by Tornier, Inc., cleared under FDA 510(k) K160975 on 10 Jun 2016, 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) K160975↗

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 · Special	NumberK160975	Date10 Jun 2016Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K160975

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K160975
FDA product code: KWS

Device class: Class II
Regulation: 21 CFR Part 888.3660
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

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