FDA.reportPublic FDA data

CarboClear Hybrid Pedicle Screw System

Primary DI
17290117352318
Brand
CarboClear Hybrid Pedicle Screw System
Company
CARBOFIX ORTHOPEDICS LTD
Model
Pedicle Screw
Catalog number
HYB5535
Device description
Hybrid Pedicle Screw
Published
2024-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMLBone Cement, Posterior Screw Augmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMLBone Cement, Posterior Screw AugmentationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240846000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240846000CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone CementCarboFix Orthopedics , Ltd.2024-04-25NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290117352318PackageGS12In Commercial Distribution
07290117352311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011735231817290117352318
07290117352311072901173523117290117352311

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length35Millimeter
Outer Diameter5.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-408-0120usa@carbo-fix.com

Regulatory Flags#

DUNS number
649185170
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290117351024CarboClear Posterior Cervical Screw SystemDrill BitCS0122024-06-05
07290110209780CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5020N2021-06-29
07290110209797CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5025N2021-06-28
07290110209803CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5030N2021-06-28
07290110209810CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5035N2021-06-28
07290110209827CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5040N2021-06-28
07290110209834CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5045N2021-06-28
07290123860107CarboClear Posterior Cervical Screw SystemHybrid Angle AdjusterHCS062026-03-30
07290123860114CarboClear Posterior Cervical Screw SystemHybrid Counter TorqueHCS072026-03-30
07290117356869CarboClear Posterior Cervical Screw SystemSet ScrewHCS40002026-03-25
07290117356906CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40182026-03-25
07290117356913CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40202026-03-25
07290117356920CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40222026-03-25
07290117356937CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40242026-03-25
07290117356944CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40262026-03-25
07290117356951CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40282026-03-25
07290117356968CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40302026-03-25
07290117356975CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40322026-03-25
07290117356982CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40342026-03-25
07290117356999CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40362026-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640172554227VADER Pedicle System, Nut Screw, Tiicotec AGPML2026-04-30
07640172554234VADER Pedicle System, Cross-Link, Ti, 30/34 mmicotec AGPML2026-04-30
07640172554241VADER Pedicle System, Cross-Link, Ti, 33/42 mmicotec AGPML2026-04-30
07640172554258VADER Pedicle System, Cross-Link, Ti, 40/53 mmicotec AGPML2026-04-30
07640172554265VADER Pedicle System, Cross-Link, Ti, 50/70 mmicotec AGPML2026-04-30
07640172553909icotec Systems, Saw bladeicotec AGPML2025-09-01
07640172553848"icotec Systems, Handle, 1/4"" Coupling"icotec AGPML2025-08-13
07640172553855icotec Systems, Fixation deviceicotec AGPML2025-08-13
07640172553862icotec Systems, Deburring toolicotec AGPML2025-08-13
07640172553879icotec Systems, Handle for deburrer, M6icotec AGPML2025-08-13
07640172552537VADER Pedicle System, Trephine for Ø 4.5 mm Screw, Ø 4.5 mmicotec AGPML2025-06-02
07640172552858VADER Pedicle System, Axial Connector, Ø 6.0 mm - Ø 6.0 mmicotec AGPML2025-03-05
07640172552865VADER Pedicle System, Parallel Connector, Closed, Ø 6.0 mm - Ø 6.0 mmicotec AGPML2025-03-05
07640172552872icotec Systems, Torque-Limiting Adapter, 3.5 Nmicotec AGPML2025-03-05
07640172552889VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nmicotec AGPML2025-03-05
07640172553572VADER Pedicle System, Torque Wrench for Connectors, T15, 3.5 Nmicotec AGPML2025-03-05
07640172552742VADER Pedicle System, VADER Pedicle System Rod-2-size, Container, completeicotec AGPML2023-09-08
07640305165481PERLA® TL MISSpineArt SAPML2023-06-27
07640305165504PERLA® TL MISSpineArt SAPML2023-06-27
07640305165511PERLA® TL MISSpineArt SAPML2023-06-27
07640172551950VADER Pedicle System, Saw bladeicotec AGPML2023-01-13
07640172552285VADER Pedicle System, Trephine for Ø 5.5 mm Screw, Ø 5.5 mmicotec AGPML2023-01-13
07640172552292VADER Pedicle System, Trephine for Ø 6.5 mm Screw, Ø 6.5 mmicotec AGPML2023-01-13
07640172552308VADER Pedicle System, Trephine for Ø 7.5 mm Screw, Ø 7.5 mmicotec AGPML2023-01-13
07640172551967"VADER Pedicle System, Handle, 1/4"" Coupling"icotec AGPML2023-01-13
07640172551981VADER Pedicle System, Deburring toolicotec AGPML2023-01-13
07640172551998VADER Pedicle System, Trial rod, flexible, Ø 5.5 mm; L = 300 mmicotec AGPML2023-01-13
07640172552001VADER Pedicle System, Template for HT S-rodsicotec AGPML2023-01-13
07640172552018VADER Pedicle System, Template for TL S-rodsicotec AGPML2023-01-13
07640172552025VADER Pedicle System, Template for L S-rodsicotec AGPML2023-01-13