CarboClear Lumbar Cage System CCLC9007

GUDID 07290110206413

A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, the Shaver width also enables estimation of the intervertebral space height.

CARBOFIX ORTHOPEDICS LTD

Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable
Primary Device ID07290110206413
NIH Device Record Keyc0125875-7643-41af-bbc0-c1e7f5cbf4da
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarboClear Lumbar Cage System
Version Model NumberShaver – 7 mm
Catalog NumberCCLC9007
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
GS107290110206413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290110206413]

Moist Heat or Steam Sterilization


[07290110206413]

Moist Heat or Steam Sterilization


[07290110206413]

Moist Heat or Steam Sterilization


[07290110206413]

Moist Heat or Steam Sterilization


[07290110206413]

Moist Heat or Steam Sterilization


[07290110206413]

Moist Heat or Steam Sterilization


[07290110206413]

Moist Heat or Steam Sterilization


[07290110206413]

Moist Heat or Steam Sterilization


[07290110206413]

Moist Heat or Steam Sterilization


[07290110206413]

Moist Heat or Steam Sterilization


[07290110206413]

Moist Heat or Steam Sterilization


[07290110206413]

Moist Heat or Steam Sterilization


[07290110206413]

Moist Heat or Steam Sterilization


[07290110206413]

Moist Heat or Steam Sterilization


[07290110206413]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-08
Device Publish Date2020-05-31

On-Brand Devices [CarboClear Lumbar Cage System]

07290110206666A lumbar intervertebral body fusion device
07290110206659A lumbar intervertebral body fusion device
07290110206642A lumbar intervertebral body fusion device
07290110206543A lumbar intervertebral body fusion device
07290110206536A lumbar intervertebral body fusion device
07290110206529A lumbar intervertebral body fusion device
07290110206512A lumbar intervertebral body fusion device
07290110206505A lumbar intervertebral body fusion device
07290110206628A surgical tool used for the introduction of bone graft into the intervertebral space.
07290110206574A surgical tool used with the Implant Trials, if required, to assist in Trial removal from the d
07290110206499A T-Handle to be used with Cage Shavers and Trials.
07290110206482A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, t
07290110206475A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, t
07290110206468A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, t
07290110206451A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, t
07290110206444A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, t
07290110206437A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, t
07290110206420A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, t
07290110206413A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, t
07290110208745A lumbar intervertebral body fusion device
07290110208738A lumbar intervertebral body fusion device
07290110208721A lumbar intervertebral body fusion device
07290110208714A lumbar intervertebral body fusion device
07290110208844A lumbar intervertebral body fusion device
07290110208837A lumbar intervertebral body fusion device
07290110208820A lumbar intervertebral body fusion device
07290110208813A lumbar intervertebral body fusion device
07290110208806A lumbar intervertebral body fusion device
07290110208790A lumbar intervertebral body fusion device
07290110208783A lumbar intervertebral body fusion device
07290110208776A lumbar intervertebral body fusion device
07290110208769A lumbar intervertebral body fusion device
07290110208752A lumbar intervertebral body fusion device
07290110208684A surgical tool used for the introduction of the CarboClear Lumbar Cage into the disc space.

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