Davantis/Antelys Vertebral Body Replacements

FDA 510(k) K053292 · Scient'X USA, Inc.

Substantially Equivalent

510(k) numberK053292

Submission

Device name
Davantis/Antelys Vertebral Body Replacements
Applicant
Scient'X USA, Inc.
Round Rock, TX, US
Received
November 25, 2005
Decision date
January 19, 2006
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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Questions and answers

When was Davantis/Antelys Vertebral Body Replacements cleared by the FDA?

Davantis/Antelys Vertebral Body Replacements (K053292) received a 510(k) decision of Substantially Equivalent on January 19, 2006, 55 days after the submission was received.

What is the product code of K053292?

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