Cannula with Round Tip Stylet

Cannula with Round Tip Stylet
NA - 0407255000

A sterile, manual, tubular device designed to create a percutaneous access channel into a vertebral body prior to and during injection of orthopaedic cement into the vertebral body during kyphoplasty. It is typically inserted under fluoroscopic guidance to treat a patient diagnosed with vertebral compression fractures (VCFs) in the lumbar or thoracic region of the spine. The device is typically made of stainless steel with an attached plastic handle and available in a kit of several equal size cannulae (e.g., 3 or 6) to provide access to one or more sites of intervention. This is a single-use device.

No Data Available

• Length: 15.24 Centimeter
• Needle Gauge: 17.0 Gauge

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: HRX

Device Name: Arthroscope

Device Class: 2

Physical State: N/A

Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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: N

Target Area: N/A

Regulation Number: 888.1100

Third Party Flag: Y

Medical Specialty: OR

Device Id: 34546540905285

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04546540905284

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: pack

Device Id: 04546540905284

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