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FDA 510(k)

TCAT (R) THA Instrument Tray Set

K-Number: K180127 · 2019-03-15

ApplicantTHINK Surgical, Inc.
Decision Date2019-03-15
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TCAT (R) THA Instrument Tray Set is a medical device manufactured by THINK Surgical, Inc.. It received FDA 510(k) clearance on 2019-03-15 under approval number K180127. 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 (R) THA Instrument Tray Set?

TCAT (R) THA Instrument Tray Set is a medical device that received FDA 510(k) clearance on 2019-03-15. It is manufactured by THINK Surgical, Inc.. The 510(k) number is K180127.

When was TCAT (R) THA Instrument Tray Set approved by the FDA?

TCAT (R) THA Instrument Tray Set received FDA 510(k) clearance on 2019-03-15, under approval number K180127.

What company makes TCAT (R) THA Instrument Tray Set?

TCAT (R) THA Instrument Tray Set is manufactured by THINK Surgical, Inc..

What is the FDA product code for TCAT (R) THA Instrument Tray Set?

The FDA product code for TCAT (R) THA 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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