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FDA 510(k)

AltiVate Anatomic Canal-Sparing (CS) Shoulder

K-Number: K193226 · 2020-06-03

ApplicantEncore Medical L.P.
Decision Date2020-06-03
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AltiVate Anatomic Canal-Sparing (CS) Shoulder is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2020-06-03 under approval number K193226. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AltiVate Anatomic Canal-Sparing (CS) Shoulder?

AltiVate Anatomic Canal-Sparing (CS) Shoulder is a medical device that received FDA 510(k) clearance on 2020-06-03. It is manufactured by Encore Medical L.P.. The 510(k) number is K193226.

When was AltiVate Anatomic Canal-Sparing (CS) Shoulder approved by the FDA?

AltiVate Anatomic Canal-Sparing (CS) Shoulder received FDA 510(k) clearance on 2020-06-03, under approval number K193226.

What company makes AltiVate Anatomic Canal-Sparing (CS) Shoulder?

AltiVate Anatomic Canal-Sparing (CS) Shoulder is manufactured by Encore Medical L.P..

What is the FDA product code for AltiVate Anatomic Canal-Sparing (CS) Shoulder?

The FDA product code for AltiVate Anatomic Canal-Sparing (CS) Shoulder is PKC.

Related Clinical Trials

NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_RECRUITING NCT05500066 Tornier HRS (Humeral Reconstruction System) Study (REVIVE) ENROLLING_BY_INVITATION

Other Devices by Encore Medical L.P.

K162024AltiVate Anatomic Shoulder System K161610EXPRT Revision Hip System K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) K160342EMPOWR PS Knee System K173073AltiVate Anatomic to Reverse Conversion Module K172651FMP Extended Liners

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Related Devices (Code: PKC)

K171858Sidus Stem-Free ShoulderZimmer GmbH K173388Exactech Equinoxe Stemless ShoulderExactech, Inc. K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc. K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, 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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