CarboClear Modular Hybrid Pedicle Screw System HMS5045F

GUDID 07290117357606

CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw

CARBOFIX ORTHOPEDICS LTD

Spinal bone screw, non-bioabsorbable
Primary Device ID07290117357606
NIH Device Record Key24608a94-9b8b-406e-a67e-df776218c2e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarboClear Modular Hybrid Pedicle Screw System
Version Model NumberPedicle Screw
Catalog NumberHMS5045F
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
Phone1-800-408-0120
Emailusa@carbo-fix.com

Device Dimensions

Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter
Outer Diameter5 Millimeter
Length45 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290117357606 [Primary]
GS117290117357603 [Package]
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 Date2025-05-27
Device Publish Date2025-05-19

On-Brand Devices [CarboClear Modular Hybrid Pedicle Screw System]

07290117357644CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
07290117357637CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
07290117357620CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
07290117357613CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
07290117357606CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
07290117357590CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
17290117357580CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
17290117357733CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
17290117357726CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
17290117357719CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
17290117357702CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
17290117357696CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
17290117357689CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
17290117357672CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
17290117357665CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
17290117357658CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.