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FDA 510(k)

Alteon Acetabular Cup System

K-Number: K182502 · 2019-03-13

ApplicantExactech, Inc.
Decision Date2019-03-13
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Alteon Acetabular Cup System is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2019-03-13 under approval number K182502. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alteon Acetabular Cup System?

Alteon Acetabular Cup System is a medical device that received FDA 510(k) clearance on 2019-03-13. It is manufactured by Exactech, Inc.. The 510(k) number is K182502.

When was Alteon Acetabular Cup System approved by the FDA?

Alteon Acetabular Cup System received FDA 510(k) clearance on 2019-03-13, under approval number K182502.

What company makes Alteon Acetabular Cup System?

Alteon Acetabular Cup System is manufactured by Exactech, Inc..

What is the FDA product code for Alteon Acetabular Cup System?

The FDA product code for Alteon Acetabular Cup System is LPH.

Related Clinical Trials

NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING

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Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, 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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