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FDA 510(k)

CorticaLINK Spinal Fusion Platform

K-Number: K160722 · 2016-07-07

ApplicantFacetlink Dba Linkspine
Decision Date2016-07-07
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CorticaLINK Spinal Fusion Platform is the device name listed in this FDA 510(k) record. The listed applicant is Facetlink Dba Linkspine. It received FDA 510(k) clearance on 2016-07-07 under 510(k) number K160722. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CorticaLINK Spinal Fusion Platform?

CorticaLINK Spinal Fusion Platform is a medical device that received FDA 510(k) clearance on 2016-07-07. The listed applicant is Facetlink Dba Linkspine. The 510(k) number is K160722.

When did CorticaLINK Spinal Fusion Platform receive FDA 510(k) clearance?

CorticaLINK Spinal Fusion Platform received FDA 510(k) clearance on 2016-07-07, under 510(k) number K160722.

Who is the listed applicant for CorticaLINK Spinal Fusion Platform?

The FDA 510(k) record lists Facetlink Dba Linkspine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CorticaLINK Spinal Fusion Platform?

The FDA product code for CorticaLINK Spinal Fusion Platform is NKB.

Other records listing Facetlink Dba Linkspine as applicant

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.

K162693VertebraLINK Fusion Platform

Related Devices (Code: NKB)

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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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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