CarboClear Cervical Plate System CERVP3470

GUDID 07290110207007

Anterior fixation cervical plate

CARBOFIX ORTHOPEDICS LTD

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID07290110207007
NIH Device Record Keya509315f-304f-4017-9d7a-82b5575d10b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarboClear Cervical Plate System
Version Model NumberCervical Plate 3 levels 47 mm
Catalog NumberCERVP3470
Company DUNS649185170
Company NameCARBOFIX ORTHOPEDICS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com

Device Dimensions

Length47 Millimeter
Length47 Millimeter
Length47 Millimeter
Length47 Millimeter
Length47 Millimeter
Length47 Millimeter
Length47 Millimeter
Length47 Millimeter
Length47 Millimeter
Length47 Millimeter
Length47 Millimeter
Length47 Millimeter
Length47 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110207007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-18
Device Publish Date2020-06-08

On-Brand Devices [CarboClear Cervical Plate System]

07290110207342Self-drilling screw for use with CarboClear Cervical Plate.
07290110207335Self-drilling screw for use with CarboClear Cervical Plate.
07290110207328Self-drilling screw for use with CarboClear Cervical Plate.
07290110207311Self-drilling screw for use with CarboClear Cervical Plate.
07290110207304Self-drilling screw for use with CarboClear Cervical Plate.
07290110207298Self-drilling screw for use with CarboClear Cervical Plate.
07290110207281Self-drilling screw for use with CarboClear Cervical Plate.
07290110207274Self-drilling screw for use with CarboClear Cervical Plate.
07290110207267Self-drilling screw for use with CarboClear Cervical Plate.
07290110207250Self-drilling screw for use with CarboClear Cervical Plate.
07290110207243Self-drilling screw for use with CarboClear Cervical Plate.
07290110207236Sterilization case for use with the CarboClear Cervical Plate System.
07290110207229Intended to assist in determining the required plate length during operation.
07290110207212Following screw hole preparation, where applicable, the gauge may be used to measure depth and t
07290110207205Intended for locking the drill bits stopper in place.
07290110207199Used to prepare the screw canal in combination with the Cervical Drill Guide.
07290110207182Used to prepare the screw canal in combination with the Cervical Drill Guide.
07290110207175Used to direct the drill bit to prepare the screw pathway.
07290110207168Used to gain access through the bone cortex.
07290110207151Used to hold the plate during screw hole preparation.
07290110207144Used to securely hold the plate for proper placement and positioning.
07290110208554Used to securely hold the plate for proper placement and positioning.
07290110208547Used to securely hold the plate for proper placement and positioning.
07290110208653Patient-Specific anterior fixation cervical plate
07290110207137Anterior fixation cervical plate
07290110207120Anterior fixation cervical plate
07290110207113Anterior fixation cervical plate
07290110207106Anterior fixation cervical plate
07290110207090Anterior fixation cervical plate
07290110207083Anterior fixation cervical plate
07290110207076Anterior fixation cervical plate
07290110207069Anterior fixation cervical plate
07290110207052Anterior fixation cervical plate
07290110207045Anterior fixation cervical plate
07290110207038Anterior fixation cervical plate
07290110207021Anterior fixation cervical plate
07290110207014Anterior fixation cervical plate
07290110207007Anterior fixation cervical plate
07290110206994Anterior fixation cervical plate
07290110206987Anterior fixation cervical plate
07290110206970Anterior fixation cervical plate
07290110206963Anterior fixation cervical plate
07290110206956Anterior fixation cervical plate
07290110206949Anterior fixation cervical plate
07290110206932Anterior fixation cervical plate
07290110206925Anterior fixation cervical plate
07290110206918Anterior fixation cervical plate
07290110206901Anterior fixation cervical plate
07290110206895Anterior fixation cervical plate
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