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FDA 510(k)

Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings

K-Number: K190656 · 2019-12-06

ApplicantZimmer, Inc.
Decision Date2019-12-06
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2019-12-06 under approval number K190656. 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 Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings?

Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings is a medical device that received FDA 510(k) clearance on 2019-12-06. It is manufactured by Zimmer, Inc.. The 510(k) number is K190656.

When was Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings approved by the FDA?

Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings received FDA 510(k) clearance on 2019-12-06, under approval number K190656.

What company makes Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings?

Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings is manufactured by Zimmer, Inc..

What is the FDA product code for Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings?

The FDA product code for Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings is LPH.

Related Clinical Trials

NCT07544264 Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component NOT_YET_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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