ALLY MONOFILAMENT CERCLAGE SYSTEM

Basic Information

• Brand Name: ALLY MONOFILAMENT CERCLAGE SYSTEM
• Primary DI: 00880304360778
• Version / Model: 350843
• Catalog Number: 350843
• Company Name: Biomet Orthopedics, LLC
• Labeler DUNS: 129278169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 4
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 8bdb3fd5-5a17-4c0b-bf96-d3fae30bec21

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRS	PLATE, FIXATION, BONE	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44798	Internal spinal fixation system cable crimp	An implantable device intended to be used as part of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is used to lock implanted spinal fixation cable(s) after the surgeon has appropriately tensioned them. It is made of high-grade stainless steel alloy or medical grade titanium (Ti), and is locked around the cable with a dedicated cable crimper.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00880304360778	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K993510	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			18 GA