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FDA 510(k)

Lucent XP, Lucent XP Curved

K-Number: K202298 · 2020-12-22

ApplicantSpinal Elements, Inc.
Decision Date2020-12-22
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Lucent XP, Lucent XP Curved 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 2020-12-22 under 510(k) number K202298. 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 XP, Lucent XP Curved?

Lucent XP, Lucent XP Curved is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K202298.

When did Lucent XP, Lucent XP Curved receive FDA 510(k) clearance?

Lucent XP, Lucent XP Curved received FDA 510(k) clearance on 2020-12-22, under 510(k) number K202298.

Who is the listed applicant for Lucent XP, Lucent XP Curved?

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 XP, Lucent XP Curved?

The FDA product code for Lucent XP, Lucent XP Curved is MAX.

Other records listing Spinal Elements, Inc. as applicant

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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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