CarboClear X Pedicle Screw System XDT5535

GUDID 17290117355135

CarboClear X Dual Thread Pedicle Screw Solid

CARBOFIX ORTHOPEDICS LTD

Spinal bone screw, non-bioabsorbable
Primary Device ID17290117355135
NIH Device Record Keyd58fb781-86a6-4ef9-ba5c-737c27e7cbc9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarboClear X Pedicle Screw System
Version Model NumberPedicle Screw - Dual Thread
Catalog NumberXDT5535
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
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

Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290117355138 [Primary]
GS117290117355135 [Package]
Contains: 07290117355138
Package: [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-11
Device Publish Date2025-04-03

On-Brand Devices [CarboClear X Pedicle Screw System]

17290110209947Cannulated pedicle screw
17290110209930Cannulated pedicle screw
17290110209923Cannulated pedicle screw
17290110209916Cannulated pedicle screw
17290110209909Cannulated pedicle screw
17290110209893Cannulated pedicle screw
17290110209886Cannulated pedicle screw
07290110209872Cannulated pedicle screw
17290110209831Non-cannulated pedicle screw
17290110209824Non-cannulated pedicle screw
17290110209817Non-cannulated pedicle screw
17290110209800Non-cannulated pedicle screw
17290110209794Non-cannulated pedicle screw
17290110209787Non-cannulated pedicle screw
17290110207370Locking Element (Set Screw) for use as part of the CarboClear X Pedicle Screw System
17290110206830Non-cannulated pedicle screw
17290110206823Non-cannulated pedicle screw
17290110206816Non-cannulated pedicle screw
17290110206809Non-cannulated pedicle screw
17290110206793Non-cannulated pedicle screw
17290110206786Non-cannulated pedicle screw
17290110206779Non-cannulated pedicle screw
17290110206762Non-cannulated pedicle screw
17290110206755Non-cannulated pedicle screw
17290110206748Non-cannulated pedicle screw
17290110206731Non-cannulated pedicle screw
17290110206724Non-cannulated pedicle screw
17290110206717Non-cannulated pedicle screw
17290110206700Non-cannulated pedicle screw
07290117350065Pedicle Screw Navigated Screwdriver for use with the CarboClear X Pedicle Screw System.
07290117350058An adaptor for the Pedicle Screw Navigated Screwdriver for use with the CarboClear X Pedicle Scr
07290117350041Set Screw Starter for use with the CarboClear X Pedicle Screw System.
07290117350034Handle for use with the Rod Reducer of the CarboClear X Pedicle Screw System.
07290117350027Counter-torque for use with the CarboClear X Pedicle Screw System.
07290117350010Set Screw Locker for use with the CarboClear X Pedicle Screw System.
07290117350003Tulip Adjuster for use with the CarboClear X Pedicle Screw System.
07290110209995Tulip Adjuster for use with the CarboClear X Pedicle Screw System.
07290110209971Pedicle Screw Screwdriver for use with the CarboClear X Pedicle Screw System.
07290110209964Sterilization case for use with the CarboClear X Pedicle Screw System.
17290117350444Fenestrated pedicle screw (oncology)
17290117350437Fenestrated pedicle screw (oncology)
17290117350420Fenestrated pedicle screw (oncology)
17290117350413Fenestrated pedicle screw (oncology)
17290117350406Fenestrated pedicle screw (oncology)
17290117350390Fenestrated pedicle screw (oncology)
17290117350383Fenestrated pedicle screw (oncology)
17290117350376Fenestrated pedicle screw (oncology)
17290117350369Fenestrated pedicle screw (oncology)
17290117350352Fenestrated pedicle screw (oncology)
17290117350345Fenestrated pedicle screw (oncology)
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