OZARK Cervical Plate System

Basic Information

• Brand Name: OZARK Cervical Plate System
• Primary DI: 10888857369290
• Version / Model: 8801-90007
• Catalog Number: 8801-90007
• Company Name: K2M, INC.
• Labeler DUNS: 146060863
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-31
• Public Version: 3
• Public Version Date: 2023-11-06
• Public Version Status: Update
• Public Device Record Key: 9fabb039-f4b1-45e2-9cd0-9f9e39f41c23

Device Description

Temporary Fixation Pin 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: Labeling does not contain MRI Safety Information
• 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
61918	Orthopaedic bone pin container	A non-sterile cylindrical device intended to temporarily hold one or more orthopaedic pin(s) [e.g., K-wires] during sterilization and a surgical procedure for protection against damage. It is made of metal (e.g., stainless steel) and is typically a cylinder with a screw top, with lateral fenestrations to enable the penetration of sterilization fluid. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888857369290	GS1

Customer Contacts

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