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FDA 510(k)

MODIFICATION TO LUCENT

K-Number: K081968 · 2008-08-05

ApplicantSpinal Elements, Inc.
Decision Date2008-08-05
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO 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 2008-08-05 under 510(k) number K081968. 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 MODIFICATION TO LUCENT?

MODIFICATION TO LUCENT is a medical device that received FDA 510(k) clearance on 2008-08-05. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K081968.

When did MODIFICATION TO LUCENT receive FDA 510(k) clearance?

MODIFICATION TO LUCENT received FDA 510(k) clearance on 2008-08-05, under 510(k) number K081968.

Who is the listed applicant for MODIFICATION TO 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 MODIFICATION TO LUCENT?

The FDA product code for MODIFICATION TO LUCENT is MAX.

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Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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