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FDA 510(k)

Cemented Origin Hip Stem

K-Number: K201951 · 2020-07-31

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2020-07-31
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cemented Origin Hip Stem is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K201951. 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 Cemented Origin Hip Stem?

Cemented Origin Hip Stem is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K201951.

When did Cemented Origin Hip Stem receive FDA 510(k) clearance?

Cemented Origin Hip Stem received FDA 510(k) clearance on 2020-07-31, under 510(k) number K201951.

Who is the listed applicant for Cemented Origin Hip Stem?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cemented Origin Hip Stem?

The FDA product code for Cemented Origin Hip Stem is LZO.

Other records listing Signature Orthopaedics Pty, Ltd. 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.

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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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