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FDA 510(k)

CarboClear VBR System

K-Number: K192214 · 2019-10-11

ApplicantCarboFix Orthopedics , Ltd.
Decision Date2019-10-11
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CarboClear VBR System 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 2019-10-11 under 510(k) number K192214. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CarboClear VBR System?

CarboClear VBR System is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K192214.

When did CarboClear VBR System receive FDA 510(k) clearance?

CarboClear VBR System received FDA 510(k) clearance on 2019-10-11, under 510(k) number K192214.

Who is the listed applicant for CarboClear VBR System?

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 VBR System?

The FDA product code for CarboClear VBR System is MQP.

Other records listing CarboFix Orthopedics , Ltd. 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.

K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemK243106CarboClear® Hybrid Pedicle Screw SystemK233793CarboClear® X Pedicle Screw SystemK240846CarboClear® 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 CementK233989CarboClear® Posterior Cervical Screw SystemK233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments

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Related Devices (Code: MQP)

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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

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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