Creaspine Supstance Vertebral Body Replacement System Line Extension

FDA 510(k) K081564 · Creaspine

Substantially Equivalent

510(k) numberK081564

Submission

Device name
Creaspine Supstance Vertebral Body Replacement System Line Extension
Applicant
Creaspine
North Attleboro, MA, US
Received
June 4, 2008
Decision date
June 30, 2008
Decision
Substantially Equivalent (SESE)
Type
Special 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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More from Corelink, LLC

510(k)DeviceDecision
K080860Creaspine Supstance Small Vertebral Body Replacement SystemMQP · Traditional 05/29/2008SE
K072537Creaspine Supstance Vertebral Body Replacement SystemMQP · Traditional 12/18/2007SE

Questions and answers

When was Creaspine Supstance Vertebral Body Replacement System Line Extension cleared by the FDA?

Creaspine Supstance Vertebral Body Replacement System Line Extension (K081564) received a 510(k) decision of Substantially Equivalent on June 30, 2008, 26 days after the submission was received.

What is the product code of K081564?

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