Kyphon Anchor Facet Screw System

FDA 510(k) K101765 · Medtronic Spine, LLC

Substantially Equivalent

510(k) numberK101765

Submission

Device name
Kyphon Anchor Facet Screw System
Applicant
Medtronic Spine, LLC
Sunnyvale, CA, US
Received
June 23, 2010
Decision date
October 22, 2010
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 Kyphon Anchor Facet Screw System cleared by the FDA?

Kyphon Anchor Facet Screw System (K101765) received a 510(k) decision of Substantially Equivalent on October 22, 2010, 121 days after the submission was received.

What is the product code of K101765?

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