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FDA 510(k)

Life Spine Lumbar Fixation System (SENTRY)

K-Number: K180166 · 2018-06-22

ApplicantLife Spine, Inc.
Decision Date2018-06-22
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Life Spine Lumbar Fixation System (SENTRY) is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2018-06-22 under 510(k) number K180166. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Life Spine Lumbar Fixation System (SENTRY)?

Life Spine Lumbar Fixation System (SENTRY) is a medical device that received FDA 510(k) clearance on 2018-06-22. The listed applicant is Life Spine, Inc.. The 510(k) number is K180166.

When did Life Spine Lumbar Fixation System (SENTRY) receive FDA 510(k) clearance?

Life Spine Lumbar Fixation System (SENTRY) received FDA 510(k) clearance on 2018-06-22, under 510(k) number K180166.

Who is the listed applicant for Life Spine Lumbar Fixation System (SENTRY)?

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

What is the FDA product code for Life Spine Lumbar Fixation System (SENTRY)?

The FDA product code for Life Spine Lumbar Fixation System (SENTRY) is KWQ.

Related Clinical Trials

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.

NCT07414745MDT-0123 Japan StudyRECRUITING

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Related Devices (Code: KWQ)

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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