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FDA 510(k)

Genesys Spine TiLock Cortical Spinal System

K-Number: K161914 · 2016-08-09

ApplicantGenesys Spine
Decision Date2016-08-09
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Genesys Spine TiLock Cortical Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Genesys Spine. It received FDA 510(k) clearance on 2016-08-09 under 510(k) number K161914. 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 Genesys Spine TiLock Cortical Spinal System?

Genesys Spine TiLock Cortical Spinal System is a medical device that received FDA 510(k) clearance on 2016-08-09. The listed applicant is Genesys Spine. The 510(k) number is K161914.

When did Genesys Spine TiLock Cortical Spinal System receive FDA 510(k) clearance?

Genesys Spine TiLock Cortical Spinal System received FDA 510(k) clearance on 2016-08-09, under 510(k) number K161914.

Who is the listed applicant for Genesys Spine TiLock Cortical Spinal System?

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

What is the FDA product code for Genesys Spine TiLock Cortical Spinal System?

The FDA product code for Genesys Spine TiLock Cortical Spinal System is NKB.

Other records listing Genesys Spine 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.

K252322SIros-X SystemK242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemK233595Genesys Spine Sacroiliac Joint Fusion System with NavigationK233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemK220096Genesys Spine 3DP Lumbar Interbody SystemK191489Genesys Spine 3DP Cervical Interbody System

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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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