TCAT TKA Instrument Tray— 510(k) K203468

Substantially Equivalent

THINK Surgical, Inc.

FDA 510(k) clearance K203468 for TCAT TKA Instrument Tray, Substantially Equivalent on 2021-12-20. 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: 2020-11-25
Decision date: 2021-12-20
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.