MIS Spine Frame Instrument Case— 510(k) K151347

Name: FDA 510(k) clearance K151347
Creator: U.S. Food and Drug Administration
Published: 2015-10-16

Substantially Equivalent

Thompson Surgical Instruments

FDA 510(k) clearance K151347 for MIS Spine Frame Instrument Case, Substantially Equivalent on 2015-10-16. Applicant: Thompson Surgical Instruments. Device class: 2.

Clearance details

Applicant: Thompson Surgical Instruments
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2015-05-20
Decision date: 2015-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Traverse City, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCT

view all

K253988 — LiteSet Trays2026-09-08
K261935 — Surgical and Prosthetic Trays2026-09-04
K253187 — SteriBest® Sterilization Tray System2026-06-18
K252854 — SteriTite Container System with MediTray Products2026-06-03
K260726 — Straumann® ProClean Cassette (041.800; 041.801)2026-06-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.