SonicFusion

Basic Information

• Brand Name: SonicFusion
• Primary DI: 07613327051292
• Version / Model: 0019102000
• Catalog Number: 0019102000
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 187502109
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: 78443021-538d-4b69-934e-1bd4c8bda600
• Distribution End Date: 2024-03-16

Device Description

Ultrasonic Generator

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTY	PIN, FIXATION, SMOOTH	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45883	Bone pin ultrasonic osteosynthesis system generator	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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327051292	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K091955	000