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FDA 510(k)

DYNA-LINK ELITE Stand-Alone Anterior Lumbar System

K-Number: K180215 · 2018-09-13

ApplicantLife Spine, Inc.
Decision Date2018-09-13
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DYNA-LINK ELITE Stand-Alone Anterior Lumbar System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2018-09-13 under approval number K180215. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNA-LINK ELITE Stand-Alone Anterior Lumbar System?

DYNA-LINK ELITE Stand-Alone Anterior Lumbar System is a medical device that received FDA 510(k) clearance on 2018-09-13. It is manufactured by Life Spine, Inc.. The 510(k) number is K180215.

When was DYNA-LINK ELITE Stand-Alone Anterior Lumbar System approved by the FDA?

DYNA-LINK ELITE Stand-Alone Anterior Lumbar System received FDA 510(k) clearance on 2018-09-13, under approval number K180215.

What company makes DYNA-LINK ELITE Stand-Alone Anterior Lumbar System?

DYNA-LINK ELITE Stand-Alone Anterior Lumbar System is manufactured by Life Spine, Inc..

What is the FDA product code for DYNA-LINK ELITE Stand-Alone Anterior Lumbar System?

The FDA product code for DYNA-LINK ELITE Stand-Alone Anterior Lumbar System is OVD.

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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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