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FDA 510(k)

CarboClear Cervical Cage System, CarboClear Cervical VBR System

K-Number: K222874 · 2023-07-26

ApplicantCarbofix Orthpedics , Ltd.
Decision Date2023-07-26
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CarboClear Cervical Cage System, CarboClear Cervical VBR System is a medical device manufactured by Carbofix Orthpedics , Ltd.. It received FDA 510(k) clearance on 2023-07-26 under approval number K222874. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CarboClear Cervical Cage System, CarboClear Cervical VBR System?

CarboClear Cervical Cage System, CarboClear Cervical VBR System is a medical device that received FDA 510(k) clearance on 2023-07-26. It is manufactured by Carbofix Orthpedics , Ltd.. The 510(k) number is K222874.

When was CarboClear Cervical Cage System, CarboClear Cervical VBR System approved by the FDA?

CarboClear Cervical Cage System, CarboClear Cervical VBR System received FDA 510(k) clearance on 2023-07-26, under approval number K222874.

What company makes CarboClear Cervical Cage System, CarboClear Cervical VBR System?

CarboClear Cervical Cage System, CarboClear Cervical VBR System is manufactured by Carbofix Orthpedics , Ltd..

What is the FDA product code for CarboClear Cervical Cage System, CarboClear Cervical VBR System?

The FDA product code for CarboClear Cervical Cage System, CarboClear Cervical VBR System is ODP.

Related Clinical Trials

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Other Devices by Carbofix Orthpedics , Ltd.

K203683CarboClear Lumbar Cage System

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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