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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 the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2020-06-03 under 510(k) 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. The listed applicant is Encore Medical L.P.. The 510(k) number is K193226.

When did AltiVate Anatomic Canal-Sparing (CS) Shoulder receive FDA 510(k) clearance?

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

Who is the listed applicant for AltiVate Anatomic Canal-Sparing (CS) Shoulder?

The FDA 510(k) record lists Encore Medical L.P. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Encore Medical L.P. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252567AltiVate Reverse® ADLC GlenosphereK252974EMPOWR KneeK251833EMPOWR Acetabular® Liner ExtensionK252141AltiVate Reverse® GlenoidK251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)

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Related Devices (Code: PKC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K243248INHANCE INTACT™Depuy Ireland UCK241873OsseoFit Stemless Shoulder SystemZimmer, Inc.K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K221758SMR Stemless AnatomicLima Corporate S.P.A.

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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