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FDA 510(k)

Lucent®

K-Number: K170235 · 2017-11-29

ApplicantSpinal Elements, Inc.
Decision Date2017-11-29
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Lucent® 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 2017-11-29 under 510(k) number K170235. 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 Lucent®?

Lucent® is a medical device that received FDA 510(k) clearance on 2017-11-29. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K170235.

When did Lucent® receive FDA 510(k) clearance?

Lucent® received FDA 510(k) clearance on 2017-11-29, under 510(k) number K170235.

Who is the listed applicant for Lucent®?

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 Lucent®?

The FDA product code for Lucent® 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.

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