FDA 510(k)

Fitmore Hip Stem

K-Number: K192236 · 2019-11-05

Decision Date2019-11-05

Product CodeKWY

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Fitmore Hip Stem is a medical device manufactured by Zimmer GmbH. It received FDA 510(k) clearance on 2019-11-05 under approval number K192236. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fitmore Hip Stem?

Fitmore Hip Stem is a medical device that received FDA 510(k) clearance on 2019-11-05. It is manufactured by Zimmer GmbH. The 510(k) number is K192236.

When was Fitmore Hip Stem approved by the FDA?

Fitmore Hip Stem received FDA 510(k) clearance on 2019-11-05, under approval number K192236.

What company makes Fitmore Hip Stem?

Fitmore Hip Stem is manufactured by Zimmer GmbH.

What is the FDA product code for Fitmore Hip Stem?

The FDA product code for Fitmore Hip Stem is KWY.

Other Devices by Zimmer GmbH

K161620Anatomical Shoulder Domelock Dome centric K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System K171858Sidus Stem-Free Shoulder K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System K170072Fitmore® Hip Stem

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Related Devices (Code: KWY)

K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation K170072Fitmore® Hip StemZimmer GmbH K173455SurgTech Bipolar Head SystemSurgtech, Inc. K180130ELEOS Bipolar Acetabular SystemOnkos Surgical, Inc. K16308140-42mm BiPolar Head and 22mm Femoral HeadSignature Orthopaedics Pty, Ltd. K191016COPAL exchange G Hip and Knee SpacersHeraeus Medical GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.