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FDA 510(k)

Conformis BeneFIT Hip System

K-Number: K190904 · 2019-08-28

ApplicantConformis, Inc.
Decision Date2019-08-28
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Conformis BeneFIT Hip System is a medical device manufactured by Conformis, Inc.. It received FDA 510(k) clearance on 2019-08-28 under approval number K190904. 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 Conformis BeneFIT Hip System?

Conformis BeneFIT Hip System is a medical device that received FDA 510(k) clearance on 2019-08-28. It is manufactured by Conformis, Inc.. The 510(k) number is K190904.

When was Conformis BeneFIT Hip System approved by the FDA?

Conformis BeneFIT Hip System received FDA 510(k) clearance on 2019-08-28, under approval number K190904.

What company makes Conformis BeneFIT Hip System?

Conformis BeneFIT Hip System is manufactured by Conformis, Inc..

What is the FDA product code for Conformis BeneFIT Hip System?

The FDA product code for Conformis BeneFIT Hip System is LPH.

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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Other Devices by Conformis, Inc.

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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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