AltiVate Anatomic Canal-Sparing (CS) Shoulder

Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained

Encore Medical, L.P

The following data is part of a premarket notification filed by Encore Medical, L.p with the FDA for Altivate Anatomic Canal-sparing (cs) Shoulder.

Pre-market Notification Details

Device IDK193226
510k NumberK193226
Device Name:AltiVate Anatomic Canal-Sparing (CS) Shoulder
ClassificationProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Applicant Encore Medical, L.P 9800 Metric Blvd Austin,  TX  78758
ContactTeffany Hutto
CorrespondentTeffany Hutto
Encore Medical, L.P 9800 Metric Blvd Austin,  TX  78758
Product CodePKC  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-22
Decision Date2020-06-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00190446648949 K193226 000

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