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FDA 510(k)

GENESYS SPINE TILOCK SYSTEM

K-Number: K103671 · 2011-07-21

ApplicantGenesys Spine
Decision Date2011-07-21
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GENESYS SPINE TILOCK 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 2011-07-21 under 510(k) number K103671. 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 SYSTEM?

GENESYS SPINE TILOCK SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-21. The listed applicant is Genesys Spine. The 510(k) number is K103671.

When did GENESYS SPINE TILOCK SYSTEM receive FDA 510(k) clearance?

GENESYS SPINE TILOCK SYSTEM received FDA 510(k) clearance on 2011-07-21, under 510(k) number K103671.

Who is the listed applicant for GENESYS SPINE TILOCK 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 SYSTEM?

The FDA product code for GENESYS SPINE TILOCK SYSTEM is NKB.

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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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ 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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