FDA 510(k)

SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE

K-Number: K111880 · 2011-09-26

Decision Date2011-09-26

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Spineology, Inc.. It received FDA 510(k) clearance on 2011-09-26 under 510(k) number K111880. 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 SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE?

SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2011-09-26. The listed applicant is Spineology, Inc.. The 510(k) number is K111880.

When did SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE receive FDA 510(k) clearance?

SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE received FDA 510(k) clearance on 2011-09-26, under 510(k) number K111880.

Who is the listed applicant for SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE?

The FDA 510(k) record lists Spineology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE?

The FDA product code for SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE is MAX.

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Related Devices (Code: MAX)

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Official Source

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