TCAT TKA Instrument Tray Set— 510(k) K200632

Name: FDA 510(k) clearance K200632
Creator: U.S. Food and Drug Administration
Published: 2020-04-08

Substantially Equivalent

THINK Surgical, Inc.

FDA 510(k) clearance K200632 for TCAT TKA Instrument Tray Set, Substantially Equivalent on 2020-04-08. Applicant: THINK Surgical, Inc.. Device class: 2.

Clearance details

Applicant: THINK Surgical, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2020-03-10
Decision date: 2020-04-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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