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510(k) K191247

SmartSPACE Shoulder System by Techmah Medical, LLC — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2019
Date Received
May 9, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Other clearances by Techmah Medical, LLC

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  • K202454 — Smart SPACE Shoulder System (December 28, 2020)

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