Threshold Pedicular Fixation System

Basic Information

• Brand Name: Threshold Pedicular Fixation System
• Primary DI: M7405300094
• Version / Model: 53-17-01
• Catalog Number: 530-0094
• Company Name: SPINEOLOGY INC.
• Labeler DUNS: 033014361
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-05
• Public Version: 1
• Public Version Date: 2024-01-15
• Public Version Status: New
• Public Device Record Key: 680de8d2-e760-4a50-80a9-e6d36db5be82

Device Description

Fixed Rod Holder

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61323	Post-PCR cleanup kit IVD	A collection of reagents and other associated materials intended to be used for the purification of polymerase chain reaction (PCR) processed clinical specimens prior to downstream nucleic acid analysis. The kit typically consists of various buffer and/or washing solutions and can be used with manual or automated instruments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M7405300094	HIBCC

Customer Contacts

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