System without Needles with HV Bone Cement

System without Needles with HV Bone Cement
AutoPlex, VertaPlex - 0607687000

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.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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