SmartSPACE Shoulder System

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

TechMah Medical LLC

The following data is part of a premarket notification filed by Techmah Medical Llc with the FDA for Smartspace Shoulder System.

Pre-market Notification Details

Device IDK191247
501k NumberK191247
Device Name:SmartSPACE Shoulder System
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant TechMah Medical LLC 2099 Thunderhead Rd., Suite 302 Knoxville,  TN  37922
ContactMohamed R. Mahfouz
CorrespondentMary Vater
Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury,  VT  05738
Product CodeKWS  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-09
Decision Date2019-11-15

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