System without Needles with HV Bone Cement
AutoPlex, VertaPlex - 0607687000
Device Description
A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.
Environmental Conditions
- 75.00
- 10.00
- 40.00
- -20.00
- 106.00
- 70.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: JDZ
Device Name: Mixer, Cement, For Clinical Use
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
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: N
Target Area: N/A
Regulation Number: 888.4210
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: 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
Device Identifiers
Device Id: 37613252039250
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 07613252039259
Package Quantity: 2
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: pack
Device Id: 07613252039259
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
