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FDA 510(k)

Conformis Hip System

K-Number: K192198 · 2019-11-06

ApplicantConformis, Inc.
Decision Date2019-11-06
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Conformis Hip System is a medical device manufactured by Conformis, Inc.. It received FDA 510(k) clearance on 2019-11-06 under approval number K192198. 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 Hip System?

Conformis Hip System is a medical device that received FDA 510(k) clearance on 2019-11-06. It is manufactured by Conformis, Inc.. The 510(k) number is K192198.

When was Conformis Hip System approved by the FDA?

Conformis Hip System received FDA 510(k) clearance on 2019-11-06, under approval number K192198.

What company makes Conformis Hip System?

Conformis Hip System is manufactured by Conformis, Inc..

What is the FDA product code for Conformis Hip System?

The FDA product code for Conformis Hip System is LPH.

Other Devices by Conformis, Inc.

K161668ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) K153721iTotal Cruciate Retaining (CR) Knee Replacement System K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System K153217ConforMIS iTotal Posterior Stabilized Knee Replacement System K170226iTotal Family Reusable Instrument Tray

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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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