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 a medical device manufactured by CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2019-10-11 under approval 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. It is manufactured by CarboFix Orthopedics , Ltd.. The 510(k) number is K192214.
When was CarboClear VBR System approved by the FDA?
CarboClear VBR System received FDA 510(k) clearance on 2019-10-11, under approval number K192214.
What company makes CarboClear VBR System?
CarboClear VBR System is manufactured by CarboFix Orthopedics , Ltd..
What is the FDA product code for CarboClear VBR System?
The FDA product code for CarboClear VBR System is MQP.
Other Devices by CarboFix Orthopedics , Ltd.
Related Devices (Code: MQP)
K172330Blustone Synergy Silica SystemBlustone Synergy
K173125T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek
K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.
K172323Omnia Medical VBROmnia Medical, LLC
K171686Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine
K171704CAPRI Corpectomy Cage SystemK2m
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.