CHAMELEON FIXATION SYSTEM— 510(k) K071420

Clearance details

Applicant

Spinefrontier, Inc.

Product code

Code MRW

Device class

Unclassified

Advisory panel

Unknown

Date received

2007-05-22

Decision date

2008-01-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Beverly, MA, US

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• Z-1871-2013 — Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition the drill guide is used as a reference to measure depth that the drills and taps are protruding into bone, which is measured by depth markings at the proximal end of the drills/taps relative to the proximal end of the drill guide. These devices were used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.Class II·Terminated·SpineFrontier, Inc.·20121109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071420.