RadioPaque Bone Cement
VertaPlex - 0406402002
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 IdentifiersDevice Id: 37613327141765
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 07613327141764
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: pack
Device Id: 07613327141764
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
Device Id: 57613327141769
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 37613327141765
Package Quantity: 2
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: case