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FDA 510(k)

Fitmore® Hip Stem

K-Number: K170072 · 2017-02-07

ApplicantZimmer GmbH
Decision Date2017-02-07
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fitmore® Hip Stem is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2017-02-07 under 510(k) number K170072. 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 2017-02-07. The listed applicant is Zimmer GmbH. The 510(k) number is K170072.

When did Fitmore® Hip Stem receive FDA 510(k) clearance?

Fitmore® Hip Stem received FDA 510(k) clearance on 2017-02-07, under 510(k) number K170072.

Who is the listed applicant for Fitmore® Hip Stem?

The FDA 510(k) record lists Zimmer GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fitmore® Hip Stem?

The FDA product code for Fitmore® Hip Stem is KWY.

Other records listing Zimmer GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P060037Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearingK261683Augment Off-Axis Instrument SystemK260831Z1 Hip SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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Related Devices (Code: KWY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253357b-ONE® Bipolar HeadB-One Ortho, Corp.K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UCK223441SpaceFlex Acetabular CupG21, S.R.L.K221794Vario-Cup SystemWaldemar Link GmbH & Co. KGK220492COPAL exchange G hip spacerHeraeus 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.

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