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FDA 510(k)

AXXION LIGHT GUIDE

K-Number: K082992 · 2009-02-18

ApplicantSpinal Elements, Inc.
Decision Date2009-02-18
Product CodeFST
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AXXION LIGHT GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2009-02-18 under 510(k) number K082992. The device is classified under product code FST. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXXION LIGHT GUIDE?

AXXION LIGHT GUIDE is a medical device that received FDA 510(k) clearance on 2009-02-18. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K082992.

When did AXXION LIGHT GUIDE receive FDA 510(k) clearance?

AXXION LIGHT GUIDE received FDA 510(k) clearance on 2009-02-18, under 510(k) number K082992.

Who is the listed applicant for AXXION LIGHT GUIDE?

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

What is the FDA product code for AXXION LIGHT GUIDE?

The FDA product code for AXXION LIGHT GUIDE is FST.

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Related Devices (Code: FST)

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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.

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