TCAT TKA Instrument Tray
K-Number: K203468 · 2021-12-20
ApplicantTHINK Surgical, Inc.
Decision Date2021-12-20
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
TCAT TKA Instrument Tray is a medical device manufactured by THINK Surgical, Inc.. It received FDA 510(k) clearance on 2021-12-20 under approval number K203468. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TCAT TKA Instrument Tray?
TCAT TKA Instrument Tray is a medical device that received FDA 510(k) clearance on 2021-12-20. It is manufactured by THINK Surgical, Inc.. The 510(k) number is K203468.
When was TCAT TKA Instrument Tray approved by the FDA?
TCAT TKA Instrument Tray received FDA 510(k) clearance on 2021-12-20, under approval number K203468.
What company makes TCAT TKA Instrument Tray?
TCAT TKA Instrument Tray is manufactured by THINK Surgical, Inc..
What is the FDA product code for TCAT TKA Instrument Tray?
The FDA product code for TCAT TKA Instrument Tray is KCT.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.