DJO SURGICAL

Basic Information

• Brand Name: DJO SURGICAL
• Primary DI: 00888912132015
• Version / Model: 801-01-658
• Company Name: DJO, LLC
• Labeler DUNS: 081840873
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-29
• Public Version: 1
• Public Version Date: 2023-07-07
• Public Version Status: New
• Public Device Record Key: 39fe1b6b-7358-41b2-8f02-a0a6e2cc6089

Device Description

MI TIBIA STYLUS ADJUSTABLE

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: Yes
• 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
46585	Tibial insert	An implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888912132015	GS1