Smart SPACE Shoulder System

Shoulder Arthroplasty Implantation System

TechMah Medical LLC

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

Pre-market Notification Details

Device IDK202151
510k NumberK202151
Device Name:Smart SPACE Shoulder System
ClassificationShoulder Arthroplasty Implantation System
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 CodeQHE  
Subsequent Product CodeKWS
Subsequent Product CodeMBF
Subsequent Product CodeOLO
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-03
Decision Date2021-02-03

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