JAZZ System

Basic Information

• Brand Name: JAZZ System
• Primary DI: 10889981257583
• Version / Model: Tensioner Gen.II -Stem 3,5-4mm
• Catalog Number: 560407
• Company Name: IMPLANET
• Labeler DUNS: 291993439
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-23
• Public Version: 1
• Public Version Date: 2021-03-03
• Public Version Status: New
• Public Device Record Key: 71c04163-94a7-4983-b33a-fcf3fa08bd7f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	888.3010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44801	Internal spinal fixation system cable tensioner	A manual, hand-held surgical instrument used during orthopaedic surgery to apply an appropriate tension to a cable that is being implanted as part of a system to provide corrective surgery for the spine. The device is typically made of high-grade stainless steel, and is designed with a low intrusion profile to minimize the surgical exposure required for tightening the cables in situ. It will also be equipped with a means for accurate and reproducible tensioning of the cable(s). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10889981257583	GS1

Premarket Submissions

Submission Number	Supplement Number
K191217	000