CarboClear Cervical Plate System PL940230

GUDID 07290110207229

Intended to assist in determining the required plate length during operation.

CARBOFIX ORTHOPEDICS LTD

Orthopaedic bone calliper Orthopaedic bone calliper Orthopaedic bone calliper Orthopaedic bone calliper Orthopaedic bone calliper Orthopaedic bone calliper Orthopaedic bone calliper Orthopaedic bone calliper Orthopaedic bone calliper Orthopaedic bone calliper Orthopaedic bone calliper Orthopaedic bone calliper Orthopaedic bone calliper Orthopaedic bone calliper Orthopaedic bone calliper
Primary Device ID07290110207229
NIH Device Record Key9776d209-6321-4b67-8988-7f0b079268d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarboClear Cervical Plate System
Version Model NumberCervical Plate Caliper
Catalog NumberPL940230
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 Usefalse
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 Identifiers

Device Issuing AgencyDevice ID
GS107290110207229 [Primary]
GS107290110207229 [Primary]
GS107290110207229 [Primary]
GS107290110207229 [Primary]
GS107290110207229 [Primary]
GS107290110207229 [Primary]
GS107290110207229 [Primary]
GS107290110207229 [Primary]
GS107290110207229 [Primary]
GS107290110207229 [Primary]
GS107290110207229 [Primary]
GS107290110207229 [Primary]
GS107290110207229 [Primary]
GS107290110207229 [Primary]
GS107290110207229 [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

[07290110207229]

Moist Heat or Steam Sterilization


[07290110207229]

Moist Heat or Steam Sterilization


[07290110207229]

Moist Heat or Steam Sterilization


[07290110207229]

Moist Heat or Steam Sterilization


[07290110207229]

Moist Heat or Steam Sterilization


[07290110207229]

Moist Heat or Steam Sterilization


[07290110207229]

Moist Heat or Steam Sterilization


[07290110207229]

Moist Heat or Steam Sterilization


[07290110207229]

Moist Heat or Steam Sterilization


[07290110207229]

Moist Heat or Steam Sterilization


[07290110207229]

Moist Heat or Steam Sterilization


[07290110207229]

Moist Heat or Steam Sterilization


[07290110207229]

Moist Heat or Steam Sterilization


[07290110207229]

Moist Heat or Steam Sterilization


[07290110207229]

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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