Handpiece
SONICFUSION - 1910-1001
Device Description
A hand-held, pen-like device intended to convert high frequency electrical current into high frequency mechanical oscillation (ultrasonic vibration) 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). This device holds a dedicated detachable sonotrode tip at the distal end and the power switch is operated through a foot-pedal connected to the generator for allowing the surgeon to control the welding process. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
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
Code: GAT
Device Name: Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: SU
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: 878.5000
Third Party Flag: N
Medical Specialty: SU
Code: MAI
Device Name: Fastener, Fixation, Biodegradable, Soft Tissue
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: 888.3030
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 07613327096019
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