CarboClear Hybrid Pedicle Screw System HYBF5530

GUDID 17290117352585

Fenestrated Hybrid Pedicle Screw (oncology)

CARBOFIX ORTHOPEDICS LTD

Spinal bone screw, non-bioabsorbable
Primary Device ID17290117352585
NIH Device Record Key614cb4a4-f155-4815-80c9-877f18049a6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarboClear Hybrid Pedicle Screw System
Version Model NumberPedicle Screw - Fenestrated
Catalog NumberHYBF5530
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
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com

Device Dimensions

Length30 Millimeter
Outer Diameter5.5 Millimeter
Length30 Millimeter
Outer Diameter5.5 Millimeter
Length30 Millimeter
Outer Diameter5.5 Millimeter
Length30 Millimeter
Outer Diameter5.5 Millimeter
Length30 Millimeter
Outer Diameter5.5 Millimeter
Length30 Millimeter
Outer Diameter5.5 Millimeter
Length30 Millimeter
Outer Diameter5.5 Millimeter
Length30 Millimeter
Outer Diameter5.5 Millimeter
Length30 Millimeter
Outer Diameter5.5 Millimeter
Length30 Millimeter
Outer Diameter5.5 Millimeter
Length30 Millimeter
Outer Diameter5.5 Millimeter
Length30 Millimeter
Outer Diameter5.5 Millimeter
Length30 Millimeter
Outer Diameter5.5 Millimeter
Length30 Millimeter
Outer Diameter5.5 Millimeter
Length30 Millimeter
Outer Diameter5.5 Millimeter
Length30 Millimeter
Outer Diameter5.5 Millimeter
Length30 Millimeter
Outer Diameter5.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290117352588 [Primary]
GS117290117352585 [Package]
Contains: 07290117352588
Package: [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PMLBone Cement, Posterior Screw Augmentation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-22
Device Publish Date2024-07-14

On-Brand Devices [CarboClear Hybrid Pedicle Screw System]

17290117353544Set Screw for use as part of the CarboClear Hybrid Pedicle Screw System
17290117352714Fenestrated Hybrid Pedicle Screw (oncology)
17290117352707Fenestrated Hybrid Pedicle Screw (oncology)
17290117352691Fenestrated Hybrid Pedicle Screw (oncology)
17290117352684Fenestrated Hybrid Pedicle Screw (oncology)
17290117352677Fenestrated Hybrid Pedicle Screw (oncology)
17290117352660Fenestrated Hybrid Pedicle Screw (oncology)
17290117352653Fenestrated Hybrid Pedicle Screw (oncology)
17290117352646Fenestrated Hybrid Pedicle Screw (oncology)
17290117352639Fenestrated Hybrid Pedicle Screw (oncology)
17290117352622Fenestrated Hybrid Pedicle Screw (oncology)
17290117352615Fenestrated Hybrid Pedicle Screw (oncology)
17290117352608Fenestrated Hybrid Pedicle Screw (oncology)
17290117352592Fenestrated Hybrid Pedicle Screw (oncology)
17290117352585Fenestrated Hybrid Pedicle Screw (oncology)
17290117352578Cannulated Hybrid Pedicle Screw
17290117352561Cannulated Hybrid Pedicle Screw
17290117352554Cannulated Hybrid Pedicle Screw
17290117352547Cannulated Hybrid Pedicle Screw
17290117352530Cannulated Hybrid Pedicle Screw
17290117352523Cannulated Hybrid Pedicle Screw
17290117352516Cannulated Hybrid Pedicle Screw
17290117352509Cannulated Hybrid Pedicle Screw
17290117352493Cannulated Hybrid Pedicle Screw
17290117352486Cannulated Hybrid Pedicle Screw
17290117352479Cannulated Hybrid Pedicle Screw
17290117352462Cannulated Hybrid Pedicle Screw
17290117352455Cannulated Hybrid Pedicle Screw
17290117352448Cannulated Hybrid Pedicle Screw
17290117352257Hybrid Pedicle Screw
17290117352240Hybrid Pedicle Screw
07290117353776Screw block holder for Hybrid Pedicle Screw
07290117353745Instrument for removing Extended Tabs of MIS Hybrid Pedicle Screw
07290117353721Bone surface reamer for use with the CarboClear Hybrid Pedicle Screw System
07290117353592Pedicle Screw Navigated Screwdriver for use with the CarboClear Hybrid Pedicle Screw System.
17290117352431Hybrid Pedicle Screw
17290117352424Hybrid Pedicle Screw
17290117352417Hybrid Pedicle Screw
17290117352400Hybrid Pedicle Screw
17290117352394Hybrid Pedicle Screw
17290117352387Hybrid Pedicle Screw
17290117352370Hybrid Pedicle Screw
17290117352363Hybrid Pedicle Screw
17290117352356Hybrid Pedicle Screw
17290117352349Hybrid Pedicle Screw
17290117352332Hybrid Pedicle Screw
17290117352325Hybrid Pedicle Screw
17290117352318Hybrid Pedicle Screw
17290117352301Hybrid Pedicle Screw
17290117352295Hybrid Pedicle Screw
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