Facet-Link Stabilization Platform

FDA 510(k) K150223 · Facet-Link, Inc.

Substantially Equivalent

510(k) numberK150223

Submission

Device name
Facet-Link Stabilization Platform
Applicant
Facet-Link, Inc.
Rockaway, NJ, US
Received
January 30, 2015
Decision date
April 28, 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
MRW – System, Facet Screw Spinal Device
Device class
Unclassified
Implant
Yes

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Questions and answers

When was Facet-Link Stabilization Platform cleared by the FDA?

Facet-Link Stabilization Platform (K150223) received a 510(k) decision of Substantially Equivalent on April 28, 2015, 88 days after the submission was received.

What is the product code of K150223?

The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.