Ultrasonic Generator

Ultrasonic Generator
SonicFusion - 0019102000

An electrically-powered unit intended to generate a high frequency electrical current used in a bone pin ultrasonic osteosynthesis system designed to briefly melt (weld) a bioabsorbable fixation pin in a surgically pre-drilled bone hole to allow its fusion and anchoring within the bone (osseointegration), and enable its bonding with a fixation plate used for internal fixation (osteosynthesis). The current is converted, typically within an electrode handpiece, into a high frequency mechanical oscillation (ultrasonic vibration); the energy produced by the device may be regulated through a foot-pedal.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: HTY

Device Name: Pin, Fixation, Smooth

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: 888.3040

Third Party Flag: N

Medical Specialty: OR

Device Id: 07613327051292

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