Bowl and Cement Cartridge

Bowl and Cement Cartridge
ACM - 0306553000

A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.

No Data Available

• Weight: 180.0 Gram

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OAR

Device Name: Injector, Vertebroplasty (Does Not Contain Cement)

Device Class: 1

Physical State: plastic syringe type device -- some embodiments may include levers or screws to increase injection force or control

Definition: Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Submission Type ID: 4

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses mechanical force to inject bone cement into vertebra

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: vertebra

Regulation Number: 888.4200

Third Party Flag: N

Medical Specialty: OR

Device Id: 34546540055393

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04546540055392

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: pack

Device Id: 04546540055392

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