CarboClear Vertebral Body Replacement System VBR3527560

GUDID 07290110206086

A spinal vertebral body replacement device

CARBOFIX ORTHOPEDICS LTD

Vertebral body prosthesis
Primary Device ID07290110206086
NIH Device Record Keyeb7d4494-da10-4968-bb1e-4bbd83685d33
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarboClear Vertebral Body Replacement System
Version Model NumberVBR Spacer
Catalog NumberVBR3527560
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

Device Dimensions

Outer Diameter35 Millimeter
Height60 Millimeter
Outer Diameter27.5 Millimeter
Outer Diameter35 Millimeter
Height60 Millimeter
Outer Diameter27.5 Millimeter
Outer Diameter35 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110206086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSpinal Vertebral Body Replacement Device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-11-07

On-Brand Devices [CarboClear Vertebral Body Replacement System]

07290110205782A spinal vertebral body replacement device
07290110206130A spinal vertebral body replacement device
07290110206123A spinal vertebral body replacement device
07290110206116A spinal vertebral body replacement device
07290110206109A spinal vertebral body replacement device
07290110206093A spinal vertebral body replacement device
07290110206086A spinal vertebral body replacement device
07290110206079A spinal vertebral body replacement device
07290110206062A spinal vertebral body replacement device
07290110206055A spinal vertebral body replacement device
07290110206048A spinal vertebral body replacement device
07290110206031A spinal vertebral body replacement device
07290110206024A spinal vertebral body replacement device
07290110206017A spinal vertebral body replacement device
07290110206000A spinal vertebral body replacement device
07290110205997A spinal vertebral body replacement device
07290110205980A spinal vertebral body replacement device
07290110205973A spinal vertebral body replacement device
07290110205966A spinal vertebral body replacement device
07290110205959A spinal vertebral body replacement device
07290110205942A spinal vertebral body replacement device
07290110205935A spinal vertebral body replacement device
07290110205928A spinal vertebral body replacement device
07290110205911A spinal vertebral body replacement device
07290110205904A spinal vertebral body replacement device
07290110205898A spinal vertebral body replacement device
07290110205881A spinal vertebral body replacement device
07290110205874A spinal vertebral body replacement device
07290110205867A spinal vertebral body replacement device
07290110205850A spinal vertebral body replacement device
07290110205843A spinal vertebral body replacement device
07290110205836A spinal vertebral body replacement device
07290110205829A spinal vertebral body replacement device
07290110205812A spinal vertebral body replacement device
07290110205805A spinal vertebral body replacement device
07290110205799A spinal vertebral body replacement device
07290110206147Handle for use with the CarboClear VBR (vertebral body replacement) System
07290110209841Patient-Specific spinal vertebral body replacement device

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