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FDA 510(k)

TCAT TKA Instrument Tray Set

K-Number: K200632 · 2020-04-08

ApplicantTHINK Surgical, Inc.
Decision Date2020-04-08
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TCAT TKA Instrument Tray Set is a medical device manufactured by THINK Surgical, Inc.. It received FDA 510(k) clearance on 2020-04-08 under approval number K200632. 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 Set?

TCAT TKA Instrument Tray Set is a medical device that received FDA 510(k) clearance on 2020-04-08. It is manufactured by THINK Surgical, Inc.. The 510(k) number is K200632.

When was TCAT TKA Instrument Tray Set approved by the FDA?

TCAT TKA Instrument Tray Set received FDA 510(k) clearance on 2020-04-08, under approval number K200632.

What company makes TCAT TKA Instrument Tray Set?

TCAT TKA Instrument Tray Set is manufactured by THINK Surgical, Inc..

What is the FDA product code for TCAT TKA Instrument Tray Set?

The FDA product code for TCAT TKA Instrument Tray Set 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.

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