CarboClear Cervical Plate System CERPS40180

GUDID 07290110207274

Self-drilling screw for use with CarboClear Cervical Plate.

CARBOFIX ORTHOPEDICS LTD

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID07290110207274
NIH Device Record Keyd0bfa503-8f5d-46c3-a560-be505efcb6fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarboClear Cervical Plate System
Version Model NumberSelf-Drilling Screw, Ø4mm x 18mm
Catalog NumberCERPS40180
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 Datefalse
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
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com

Device Dimensions

Outer Diameter4 Millimeter
Length18 Millimeter
Outer Diameter4 Millimeter
Length18 Millimeter
Outer Diameter4 Millimeter
Length18 Millimeter
Outer Diameter4 Millimeter
Length18 Millimeter
Outer Diameter4 Millimeter
Length18 Millimeter
Outer Diameter4 Millimeter
Length18 Millimeter
Outer Diameter4 Millimeter
Length18 Millimeter
Outer Diameter4 Millimeter
Length18 Millimeter
Outer Diameter4 Millimeter
Length18 Millimeter
Outer Diameter4 Millimeter
Length18 Millimeter
Outer Diameter4 Millimeter
Length18 Millimeter
Outer Diameter4 Millimeter
Length18 Millimeter
Outer Diameter4 Millimeter
Length18 Millimeter
Outer Diameter4 Millimeter
Length18 Millimeter
Outer Diameter4 Millimeter
Length18 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110207274 [Primary]
GS107290110207274 [Primary]
GS107290110207274 [Primary]
GS107290110207274 [Primary]
GS107290110207274 [Primary]
GS107290110207274 [Primary]
GS107290110207274 [Primary]
GS107290110207274 [Primary]
GS107290110207274 [Primary]
GS107290110207274 [Primary]
GS107290110207274 [Primary]
GS107290110207274 [Primary]
GS107290110207274 [Primary]
GS107290110207274 [Primary]
GS107290110207274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body
KWQAppliance, Fixation, Spinal Intervertebral Body
KWQAppliance, Fixation, Spinal Intervertebral Body
KWQAppliance, Fixation, Spinal Intervertebral Body
KWQAppliance, Fixation, Spinal Intervertebral Body
KWQAppliance, Fixation, Spinal Intervertebral Body
KWQAppliance, Fixation, Spinal Intervertebral Body
KWQAppliance, Fixation, Spinal Intervertebral Body
KWQAppliance, Fixation, Spinal Intervertebral Body
KWQAppliance, Fixation, Spinal Intervertebral Body
KWQAppliance, Fixation, Spinal Intervertebral Body
KWQAppliance, Fixation, Spinal Intervertebral Body
KWQAppliance, Fixation, Spinal Intervertebral Body
KWQAppliance, Fixation, Spinal Intervertebral Body
KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290110207274]

Moist Heat or Steam Sterilization


[07290110207274]

Moist Heat or Steam Sterilization


[07290110207274]

Moist Heat or Steam Sterilization


[07290110207274]

Moist Heat or Steam Sterilization


[07290110207274]

Moist Heat or Steam Sterilization


[07290110207274]

Moist Heat or Steam Sterilization


[07290110207274]

Moist Heat or Steam Sterilization


[07290110207274]

Moist Heat or Steam Sterilization


[07290110207274]

Moist Heat or Steam Sterilization


[07290110207274]

Moist Heat or Steam Sterilization


[07290110207274]

Moist Heat or Steam Sterilization


[07290110207274]

Moist Heat or Steam Sterilization


[07290110207274]

Moist Heat or Steam Sterilization


[07290110207274]

Moist Heat or Steam Sterilization


[07290110207274]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

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.

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