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FDA 510(k)

Medtronic Transportation/Sterilization Cassettes

K-Number: K152241 · 2016-01-20

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2016-01-20
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medtronic Transportation/Sterilization Cassettes is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2016-01-20 under 510(k) number K152241. 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 Medtronic Transportation/Sterilization Cassettes?

Medtronic Transportation/Sterilization Cassettes is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K152241.

When did Medtronic Transportation/Sterilization Cassettes receive FDA 510(k) clearance?

Medtronic Transportation/Sterilization Cassettes received FDA 510(k) clearance on 2016-01-20, under 510(k) number K152241.

Who is the listed applicant for Medtronic Transportation/Sterilization Cassettes?

The FDA 510(k) record lists Medtronic Sofamor Danek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medtronic Transportation/Sterilization Cassettes?

The FDA product code for Medtronic Transportation/Sterilization Cassettes is KCT.

Other records listing Medtronic Sofamor Danek USA, Inc. as applicant

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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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