FDA 510(k)

CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device

K-Number: K153373 · 2016-01-19

Decision Date2016-01-19

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device is a medical device manufactured by Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2016-01-19 under approval number K153373. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device?

CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device is a medical device that received FDA 510(k) clearance on 2016-01-19. It is manufactured by Medtronic Sofamor Danek. The 510(k) number is K153373.

When was CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device approved by the FDA?

CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device received FDA 510(k) clearance on 2016-01-19, under approval number K153373.

What company makes CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device?

CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device is manufactured by Medtronic Sofamor Danek.

What is the FDA product code for CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device?

The FDA product code for CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device is ODP.

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Other Devices by Medtronic Sofamor Danek

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Related Devices (Code: ODP)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.