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FDA 510(k)

EMPHASYS Femoral Stems

K-Number: K211657 · 2021-08-05

ApplicantDepuy Ireland UC
Decision Date2021-08-05
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EMPHASYS Femoral Stems is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2021-08-05 under 510(k) number K211657. 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 EMPHASYS Femoral Stems?

EMPHASYS Femoral Stems is a medical device that received FDA 510(k) clearance on 2021-08-05. The listed applicant is Depuy Ireland UC. The 510(k) number is K211657.

When did EMPHASYS Femoral Stems receive FDA 510(k) clearance?

EMPHASYS Femoral Stems received FDA 510(k) clearance on 2021-08-05, under 510(k) number K211657.

Who is the listed applicant for EMPHASYS Femoral Stems?

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

What is the FDA product code for EMPHASYS Femoral Stems?

The FDA product code for EMPHASYS Femoral Stems is LZO.

Other records listing Depuy Ireland UC 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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