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FDA 510(k)

Exactech Alteon Highly Polished Femoral Stem

K-Number: K182462 · 2018-11-08

ApplicantExactech, Inc.
Decision Date2018-11-08
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech Alteon Highly Polished Femoral Stem is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2018-11-08 under 510(k) number K182462. 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 Exactech Alteon Highly Polished Femoral Stem?

Exactech Alteon Highly Polished Femoral Stem is a medical device that received FDA 510(k) clearance on 2018-11-08. The listed applicant is Exactech, Inc.. The 510(k) number is K182462.

When did Exactech Alteon Highly Polished Femoral Stem receive FDA 510(k) clearance?

Exactech Alteon Highly Polished Femoral Stem received FDA 510(k) clearance on 2018-11-08, under 510(k) number K182462.

Who is the listed applicant for Exactech Alteon Highly Polished Femoral Stem?

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

What is the FDA product code for Exactech Alteon Highly Polished Femoral Stem?

The FDA product code for Exactech Alteon Highly Polished Femoral Stem is LZO.

Other records listing Exactech, Inc. 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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