SURGICAL CUTTING BURS— 510(k) K943540

Clearance details

Applicant

Stryker Corp.

Product code

Code DZJ

Device class

Class 2

Regulation

21 CFR 872.4120

Advisory panel

Dental

Date received

1994-07-22

Decision date

1994-11-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Portage, MI, US

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• Z-0092-2014 — REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order of a physician Driver, Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental, orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20131002

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K943540.