EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device— 510(k) K213209

Name: FDA 510(k) clearance K213209
Creator: U.S. Food and Drug Administration
Published: 2021-12-28

Substantially Equivalent

K1 Medical, LLC

FDA 510(k) clearance K213209 for EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device, Substantially Equivalent on 2021-12-28. Applicant: K1 Medical, LLC. Device class: 2.

Clearance details

Applicant: K1 Medical, LLC
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2021-09-29
Decision date: 2021-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodbridge, CT, 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

More clearances from K1 Medical, LLC

view all

K211007 — EZ-TRAXTM Persona Knee Containment Device2021-07-01
K202270 — EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device2020-12-02
K192487 — EZ-TRAX Containment Device2019-12-23

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