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 Reverse Humeral Stem, 48mm

K-Number: K190290 · 2019-04-26

Decision Date2019-04-26
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AltiVate Reverse Humeral Stem, 48mm is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2019-04-26 under approval number K190290. 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 Reverse Humeral Stem, 48mm?

AltiVate Reverse Humeral Stem, 48mm is a medical device that received FDA 510(k) clearance on 2019-04-26. It is manufactured by Encore Medical L.P.. The 510(k) number is K190290.

When was AltiVate Reverse Humeral Stem, 48mm approved by the FDA?

AltiVate Reverse Humeral Stem, 48mm received FDA 510(k) clearance on 2019-04-26, under approval number K190290.

What company makes AltiVate Reverse Humeral Stem, 48mm?

AltiVate Reverse Humeral Stem, 48mm is manufactured by Encore Medical L.P..

What is the FDA product code for AltiVate Reverse Humeral Stem, 48mm?

The FDA product code for AltiVate Reverse Humeral Stem, 48mm is KWS.

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.