FDA 510(k)

CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments

Numéro K : K210716 · 2021-04-06

Date de décision2021-04-06

Code produitNKB

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2021-04-06 under 510(k) number K210716. 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 CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments?

CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments is a medical device that received FDA 510(k) clearance on 2021-04-06. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K210716.

When did CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments receive FDA 510(k) clearance?

CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments received FDA 510(k) clearance on 2021-04-06, under 510(k) number K210716.

Who is the listed applicant for CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments?

The FDA 510(k) record lists CarboFix Orthopedics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments?

The FDA product code for CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments is NKB.

Essais cliniques associés

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Autres dossiers indiquant CarboFix Orthopedics , Ltd. en tant que demandeur

K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System K243106CarboClear® Hybrid Pedicle Screw System K233793CarboClear® X Pedicle Screw System K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement K233989CarboClear® Posterior Cervical Screw System K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments

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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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