Paramount VBR System

FDA 510(k) K062759 · Innovative Spinal Technologies, Inc.

Substantially Equivalent

510(k) numberK062759

Submission

Device name
Paramount VBR System
Applicant
Innovative Spinal Technologies, Inc.
Mansfield, MA, US
Received
September 15, 2006
Decision date
January 12, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MQP – Spinal Vertebral Body Replacement Device
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3060
Specialty
Orthopedic
Implant
Yes

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K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional Arftx Medical, LLC10/06/2022SE
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Questions and answers

When was Paramount VBR System cleared by the FDA?

Paramount VBR System (K062759) received a 510(k) decision of Substantially Equivalent on January 12, 2007, 119 days after the submission was received.

What is the product code of K062759?

The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.