CarboClear Posterior Cervical Screw System CS028

GUDID 07290117351185

Straight Rod Template for use with the CarboClear Posterior Cervical Screw System

CARBOFIX ORTHOPEDICS LTD

Surgical implant template, reusable
Primary Device ID07290117351185
NIH Device Record Keyb32bad1f-fe58-4f7f-bb0e-b232d4f80be3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarboClear Posterior Cervical Screw System
Version Model NumberTemplate - Rod
Catalog NumberCS028
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

Device Dimensions

Length80 Millimeter
Length80 Millimeter
Length80 Millimeter
Length80 Millimeter
Length80 Millimeter
Length80 Millimeter
Length80 Millimeter
Length80 Millimeter
Length80 Millimeter
Length80 Millimeter
Length80 Millimeter
Length80 Millimeter
Length80 Millimeter
Length80 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290117351185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKGPosterior Cervical Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290117351185]

Moist Heat or Steam Sterilization

[07290117351185]

Moist Heat or Steam Sterilization

[07290117351185]

Moist Heat or Steam Sterilization

[07290117351185]

Moist Heat or Steam Sterilization

[07290117351185]

Moist Heat or Steam Sterilization

[07290117351185]

Moist Heat or Steam Sterilization

[07290117351185]

Moist Heat or Steam Sterilization

[07290117351185]

Moist Heat or Steam Sterilization

[07290117351185]

Moist Heat or Steam Sterilization

[07290117351185]

Moist Heat or Steam Sterilization

[07290117351185]

Moist Heat or Steam Sterilization

[07290117351185]

Moist Heat or Steam Sterilization

[07290117351185]

Moist Heat or Steam Sterilization

[07290117351185]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-13
Device Publish Date2024-06-05

On-Brand Devices [CarboClear Posterior Cervical Screw System]

17290117353636Posterior cervical rod
17290117353629Posterior cervical rod
17290117353612Posterior cervical rod
07290117353585Pedicle Screw Extractor for use with the CarboClear Posterior Cervical Screw System
07290117353578Pedicle Screw Extractor for use with the CarboClear Posterior Cervical Screw System
07290117353561Compression device for use with the CarboClear Posterior Cervical Screw System
17290117353520Posterior cervical rod
17290117353513Posterior cervical rod
17290117353506Posterior cervical rod
17290117353490Posterior cervical rod
17290117353483Posterior cervical rod
17290117353476Posterior cervical rod
17290117353469Posterior cervical rod
17290117353452Posterior cervical rod
17290117353445Posterior cervical rod
17290117353438Posterior cervical rod
17290117353421Posterior cervical rod
17290117353414Posterior cervical rod
17290117353407Posterior cervical rod
17290117353391Posterior cervical rod
27290117353381Posterior cervical screw locking element (set screw)
17290117353377Posterior cervical screw
17290117353360Posterior cervical screw
17290117353353Posterior cervical screw
17290117353346Posterior cervical screw
17290117353339Posterior cervical screw
17290117353322Posterior cervical screw
17290117353315Posterior cervical screw
17290117353308Posterior cervical screw
17290117353292Posterior cervical screw
17290117353285Posterior cervical screw
17290117353278Posterior cervical screw
17290117353261Posterior cervical screw
17290117353254Posterior cervical screw
17290117353247Posterior cervical screw
17290117353230Posterior cervical screw
17290117353223Posterior cervical screw
07290117353219Posterior cervical screw
17290117353209Posterior cervical screw
07290117352212Sterilization Box for use with the CarboClear Posterior Cervical Screw System Instrumentation Se
07290117351215Saw for use with the CarboClear Posterior Cervical Screw System rods
07290117351208Curved Rod Template for use with the CarboClear Posterior Cervical Screw System
07290117351192Curved Rod Template for use with the CarboClear Posterior Cervical Screw System
07290117351185Straight Rod Template for use with the CarboClear Posterior Cervical Screw System
07290117351178Straight Rod Template for use with the CarboClear Posterior Cervical Screw System
07290117351154Rod End Shaper for use with the CarboClear Posterior Cervical Screw System rods
07290117351147Handle for use with the Rod Reducer of the CarboClear Posterior Cervical Screw System
07290117351130Rod Reducer (Tulip Adjuster) for use with the CarboClear Posterior Cervical Screw System
07290117351123Distraction device for use with the CarboClear Posterior Cervical Screw System
07290117351116Part of the CarboClear Posterior Cervical Screw System Instrumentation Set.
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