Tecomet Global Unite Short Stem Instrumentation

Shoulder Prosthesis, Reverse Configuration

Symmetry Medical Manufacturing Inc. DBA Tecomet, Inc.

The following data is part of a premarket notification filed by Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. with the FDA for Tecomet Global Unite Short Stem Instrumentation.

Pre-market Notification Details

Device IDK211553
510k NumberK211553
Device Name:Tecomet Global Unite Short Stem Instrumentation
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Symmetry Medical Manufacturing Inc. DBA Tecomet, Inc. 3724 North State Road 15 Warsaw,  IN  46582
ContactMike Parrish
CorrespondentDavid Furr
FDC Services LLC 8708 Capehart Cove Austin,  TX  78733
Product CodePHX  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-19
Decision Date2021-08-04

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