Identity Shoulder System

Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

Zimmer Inc.

The following data is part of a premarket notification filed by Zimmer Inc. with the FDA for Identity Shoulder System.

Pre-market Notification Details

Device IDK213856
510k NumberK213856
Device Name:Identity Shoulder System
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Applicant Zimmer Inc. P.O Box 708 Warsaw,  IN  46581 -0708
ContactPatricia Sandborn Beres
CorrespondentPatricia Sandborn Beres
Zimmer Inc. P.O Box 708 Warsaw,  IN  46581 -0708
Product CodeMBF  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
Subsequent Product CodeKWT
Subsequent Product CodePHX
CFR Regulation Number888.3670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-10
Decision Date2022-09-15

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