FDA 510(k)

PERIMETER INTERBODY FUSION DEVICE

K-Number: K090353 · 2009-09-29

Decision Date2009-09-29

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PERIMETER INTERBODY FUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2009-09-29 under 510(k) number K090353. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIMETER INTERBODY FUSION DEVICE?

PERIMETER INTERBODY FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2009-09-29. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K090353.

When did PERIMETER INTERBODY FUSION DEVICE receive FDA 510(k) clearance?

PERIMETER INTERBODY FUSION DEVICE received FDA 510(k) clearance on 2009-09-29, under 510(k) number K090353.

Who is the listed applicant for PERIMETER INTERBODY FUSION DEVICE?

The FDA 510(k) record lists Medtronic Sofamor Danek as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERIMETER INTERBODY FUSION DEVICE?

The FDA product code for PERIMETER INTERBODY FUSION DEVICE is MAX.

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Related Devices (Code: MAX)

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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.