Curette

Curette
NA - 0306621000

A hand-held manual surgical instrument intended to be used to scrape and debride tissue from a bone surface (e.g., cancellous vertebral bone of the spine) or a cavity wall during a neurosurgical procedure. It consists of a long, thin, metal shaft that terminates distally into a spoon-, scoop- or mushroom-like cutting head, that can be set at alternative angles, which enables a smooth scoring action for the creation of grooves or channels. It is typically used during percutaneous kyphoplasty to treat vertebral compression fractures (VCFs), or during craniotomy or brain microsurgery. This is a single-use device.

No Data Available

• Needle Gauge: 11.0 Gauge

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OCJ

Device Name: Spinal Channeling Instrument, Vertebroplasty

Device Class: 1

Physical State: Composed of cannula for placement within the vertebral body and cutting element that is deployed by the surgeon once the cannula is placed.

Definition: Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure. Treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions.

Submission Type ID: 4

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Device placed within cancellous bone of vertebral body and then cutting element advanced forward out of device by surgeon to create channel for cement flow.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Vertebral body.

Regulation Number: 888.4540

Third Party Flag: N

Medical Specialty: OR

Device Id: 07613252639794

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