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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 the device name listed in this FDA 510(k) record. The listed applicant is THINK Surgical, Inc.. It received FDA 510(k) clearance on 2019-03-15 under 510(k) 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. The listed applicant is THINK Surgical, Inc.. The 510(k) number is K180127.

When did TCAT (R) THA Instrument Tray Set receive FDA 510(k) clearance?

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

Who is the listed applicant for TCAT (R) THA Instrument Tray Set?

The FDA 510(k) record lists THINK Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing THINK Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261024TMINI Miniature Robotic SystemK260010TMINI® Miniature Robotic SystemK253661TMINI Miniature Robotic SystemK252544TMINI Miniature Robotic SystemK250877TMINI Miniature Robotic SystemK243481TMINI Miniature Robotic System

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Related Devices (Code: KCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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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