Radiopaque Bone Cement

Radiopaque Bone Cement
VertaPlex - 0406402015

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.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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: LON

Device Name: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.1645

Third Party Flag: N

Medical Specialty: MI

Device Id: 57613327170561

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 07613327170566

Package Quantity: 22

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: case

Device Id: 07613327170566

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