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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 the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2018-09-13 under 510(k) 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. The listed applicant is Life Spine, Inc.. The 510(k) number is K180215.

When did DYNA-LINK ELITE Stand-Alone Anterior Lumbar System receive FDA 510(k) clearance?

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

Who is the listed applicant for DYNA-LINK ELITE Stand-Alone Anterior Lumbar System?

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 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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Other records listing Life Spine, Inc. as applicant

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Related Devices (Code: OVD)

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.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, Inc.

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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