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FDA 510(k)

iTotal® Hip Replacement System

K-Number: K162719 · 2017-06-14

ApplicantConformis, Inc.
Decision Date2017-06-14
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

iTotal® Hip Replacement System is a medical device manufactured by Conformis, Inc.. It received FDA 510(k) clearance on 2017-06-14 under approval number K162719. 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 iTotal® Hip Replacement System?

iTotal® Hip Replacement System is a medical device that received FDA 510(k) clearance on 2017-06-14. It is manufactured by Conformis, Inc.. The 510(k) number is K162719.

When was iTotal® Hip Replacement System approved by the FDA?

iTotal® Hip Replacement System received FDA 510(k) clearance on 2017-06-14, under approval number K162719.

What company makes iTotal® Hip Replacement System?

iTotal® Hip Replacement System is manufactured by Conformis, Inc..

What is the FDA product code for iTotal® Hip Replacement System?

The FDA product code for iTotal® Hip Replacement System is LPH.

Related Clinical Trials

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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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