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FDA 510(k)

Birmingham Hip (BH) Dual Mobility Insert

K-Number: K171934 · 2017-11-30

ApplicantSmith & Nephew, Inc.
Decision Date2017-11-30
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Birmingham Hip (BH) Dual Mobility Insert is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2017-11-30 under approval number K171934. 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 Birmingham Hip (BH) Dual Mobility Insert?

Birmingham Hip (BH) Dual Mobility Insert is a medical device that received FDA 510(k) clearance on 2017-11-30. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K171934.

When was Birmingham Hip (BH) Dual Mobility Insert approved by the FDA?

Birmingham Hip (BH) Dual Mobility Insert received FDA 510(k) clearance on 2017-11-30, under approval number K171934.

What company makes Birmingham Hip (BH) Dual Mobility Insert?

Birmingham Hip (BH) Dual Mobility Insert is manufactured by Smith & Nephew, Inc..

What is the FDA product code for Birmingham Hip (BH) Dual Mobility Insert?

The FDA product code for Birmingham Hip (BH) Dual Mobility Insert is LPH.

Related Clinical Trials

NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_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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