MIS Spine Frame Instrument Case

Q: What is the product code of K151347?

The FDA product code is KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II (moderate risk) device regulated under 21 CFR 880.6850.

FDA 510(k) K151347 · Thompson Surgical Instruments

Substantially Equivalent

510(k) numberK151347

Submission

Device name: MIS Spine Frame Instrument Case
Applicant: Thompson Surgical Instruments
Traverse City, MI, US
Received: May 20, 2015
Decision date: October 16, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.6850
Specialty: General Hospital

Other 510(k)s with product code KCT

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K253187	SteriBest® Sterilization Tray SystemKCT · Traditional	Mastel Surgical	06/18/2026SE
K260726	Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional	Institut Straumann AG	06/03/2026SE
K252854	SteriTite Container System with MediTray ProductsKCT · Traditional	Case Medical, Inc.	06/03/2026SE
K253791	PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System LidKCT · Traditional	DePuy Mitek, Inc.	02/26/2026SE
K251614	Stainless Steel Surgical KitsKCT · Traditional	Dentsply Sirona, Inc.	02/06/2026SE
K251756	Sterilization TraysKCT · Traditional	Paragon Implant Mfg., LLC	11/14/2025SE
K251300	Plastic Surgical KitsKCT · Traditional	Dentsply Sirona, Inc.	07/22/2025SE
K243425	Guided DAS Surgical KitKCT · Traditional	Talladium España, SL	07/22/2025SE

More from Talladium España, SL

510(k)	Device	Decision
K210615	Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp…GZT · Traditional	05/13/2022SE
K080962	Lite Wand IIFST · Traditional	06/25/2008SE

Questions and answers

When was MIS Spine Frame Instrument Case cleared by the FDA?

MIS Spine Frame Instrument Case (K151347) received a 510(k) decision of Substantially Equivalent on October 16, 2015, 149 days after the submission was received.

What is the product code of K151347?

The FDA product code is KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II (moderate risk) device regulated under 21 CFR 880.6850.