Q System 28 Hip Stem

by Turnkey Intergration USA, Inc. 510(k)

Active United States

510(k) K910010

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK910010	Date12 Mar 1991Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K910010
FDA Product Code: LWJ

Device Class: Class II
Regulation: 21 CFR Part 888.3360
Advisory Committee: Orthopedic
FDA Decision: SESE Substantially Equivalent

Other devices from Turnkey Intergration USA, Inc.

May Humerus Plates

Class II
Omni-Fix, Nail System

Class II
Link Saddle Prothesis

Class II
Link Cement Plug

Class II
System 22 Valve

Class II
Lubinus Sp Ii Hip System Open recall

Class II

See all devices from Turnkey Intergration USA, Inc. →