TCAT (R) THA Instrument Tray Set— 510(k) K180127

Name: FDA 510(k) clearance K180127
Creator: U.S. Food and Drug Administration
Published: 2019-03-15

Substantially Equivalent

THINK Surgical, Inc.

FDA 510(k) clearance K180127 for TCAT (R) THA Instrument Tray Set, Substantially Equivalent on 2019-03-15. 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: 2018-01-17
Decision date: 2019-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.