- Physicians Office Resource

RadioPaque Bone Cement
VertaPlex - 0406402000

Device Description

A sterile substance intended to be used to replace cortical/cancellous bone in a vertebral body to stabilize vertebral compression fractures (VCFs) caused by cancer, osteoporosis, or trauma. The device may be a sterile powder of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)] that is mixed with its sterile diluent, or a non-PMMA-containing elastomer formed by mixing two precursors, prior to implantation typically during a balloon kyphoplasty or vertebroplasty procedure. This device does not contain an antibiotic agent. After application, this device cannot be reused.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: NDN

Device Name: Cement, Bone, Vertebroplasty

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3027

Third Party Flag: N

Medical Specialty: OR

Code: PML

Device Name: Bone Cement, Posterior Screw Augmentation

Device Class: 2

Physical State: Viscous, polymethylmethacrylate material that set hardens over time.

Definition: The device is intended to augment the fixation of screws in a posterior spinal system construct.

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device is placed within the prepared bone canal for placement of the posterior screw, and can be delivered through the screw cannulation and fenestrations.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Prepared bone canal in the posterior spine for placement of a screw.

Regulation Number: 888.3027

Third Party Flag: N

Medical Specialty: OR

Code: LOD

Device Name: Bone Cement

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3027

Third Party Flag: N

Medical Specialty: OR

Device Identifiers

Device Id: 37613154757092

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 07613154757091

Package Quantity: 2

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: pack

Device Id: 07613154757091

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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