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FDA 510(k)

U-Motion II Acetabular System— Additional sizes

K-Number: K170089 · 2017-10-06

ApplicantUnited Orthopedic Corporation
Decision Date2017-10-06
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

U-Motion II Acetabular System— Additional sizes is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K170089. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U-Motion II Acetabular System— Additional sizes?

U-Motion II Acetabular System— Additional sizes is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is United Orthopedic Corporation. The 510(k) number is K170089.

When did U-Motion II Acetabular System— Additional sizes receive FDA 510(k) clearance?

U-Motion II Acetabular System— Additional sizes received FDA 510(k) clearance on 2017-10-06, under 510(k) number K170089.

Who is the listed applicant for U-Motion II Acetabular System— Additional sizes?

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

What is the FDA product code for U-Motion II Acetabular System— Additional sizes?

The FDA product code for U-Motion II Acetabular System— Additional sizes is LZO.

Other records listing United Orthopedic Corporation as applicant

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Related Devices (Code: LZO)

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.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.

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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