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FDA 510(k)

Pro-Link® Ti Stand-Alone Cervical Spacer System

K-Number: K180642 · 2018-05-10

ApplicantLife Spine, Inc.
Decision Date2018-05-10
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pro-Link® Ti Stand-Alone Cervical Spacer 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 2018-05-10 under 510(k) number K180642. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pro-Link® Ti Stand-Alone Cervical Spacer System?

Pro-Link® Ti Stand-Alone Cervical Spacer System is a medical device that received FDA 510(k) clearance on 2018-05-10. The listed applicant is Life Spine, Inc.. The 510(k) number is K180642.

When did Pro-Link® Ti Stand-Alone Cervical Spacer System receive FDA 510(k) clearance?

Pro-Link® Ti Stand-Alone Cervical Spacer System received FDA 510(k) clearance on 2018-05-10, under 510(k) number K180642.

Who is the listed applicant for Pro-Link® Ti Stand-Alone Cervical Spacer 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 Pro-Link® Ti Stand-Alone Cervical Spacer System?

The FDA product code for Pro-Link® Ti Stand-Alone Cervical Spacer System is OVE.

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.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing Life Spine, Inc. as applicant

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Related Devices (Code: OVE)

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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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