FDA 510(k)

LOCK-IN Spinal Fixation System

Numéro K : K243281 · 2024-12-13

Date de décision2024-12-13

Code produitNKB

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

LOCK-IN Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Lock-In USA Corp. It received FDA 510(k) clearance on 2024-12-13 under 510(k) number K243281. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the LOCK-IN Spinal Fixation System?

LOCK-IN Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2024-12-13. The listed applicant is Lock-In USA Corp. The 510(k) number is K243281.

When did LOCK-IN Spinal Fixation System receive FDA 510(k) clearance?

LOCK-IN Spinal Fixation System received FDA 510(k) clearance on 2024-12-13, under 510(k) number K243281.

Who is the listed applicant for LOCK-IN Spinal Fixation System?

The FDA 510(k) record lists Lock-In USA Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOCK-IN Spinal Fixation System?

The FDA product code for LOCK-IN Spinal Fixation System is NKB.

Essais cliniques associés

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Dispositifs connexes (Code : NKB)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

Source officielle

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