Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AltiVate® Anatomic Shoulder AG e+™ with Markers

K-Number: K213387 · 2022-07-07

Decision Date2022-07-07
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AltiVate® Anatomic Shoulder AG e+™ with Markers is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2022-07-07 under approval number K213387. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AltiVate® Anatomic Shoulder AG e+™ with Markers?

AltiVate® Anatomic Shoulder AG e+™ with Markers is a medical device that received FDA 510(k) clearance on 2022-07-07. It is manufactured by Encore Medical L.P.. The 510(k) number is K213387.

When was AltiVate® Anatomic Shoulder AG e+™ with Markers approved by the FDA?

AltiVate® Anatomic Shoulder AG e+™ with Markers received FDA 510(k) clearance on 2022-07-07, under approval number K213387.

What company makes AltiVate® Anatomic Shoulder AG e+™ with Markers?

AltiVate® Anatomic Shoulder AG e+™ with Markers is manufactured by Encore Medical L.P..

What is the FDA product code for AltiVate® Anatomic Shoulder AG e+™ with Markers?

The FDA product code for AltiVate® Anatomic Shoulder AG e+™ with Markers is KWS.

Related Clinical Trials

Other Devices by Encore Medical L.P.

View all 31 devices →

Related Devices (Code: KWS)

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.