Smart SPACE Shoulder System— 510(k) K202454

Name: FDA 510(k) clearance K202454
Creator: U.S. Food and Drug Administration
Published: 2020-12-28

Substantially Equivalent

Techmah Medical, LLC

FDA 510(k) clearance K202454 for Smart SPACE Shoulder System, Substantially Equivalent on 2020-12-28. Applicant: Techmah Medical, LLC. Device class: 2.

Clearance details

Applicant: Techmah Medical, LLC
Product code: Code QHE
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2020-08-27
Decision date: 2020-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knoxville, TN, US

Download summary PDF View on FDA.gov ↗

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