3DP Lumbar Interbody

Basic Information

• Brand Name: 3DP Lumbar Interbody
• Primary DI: M719GLL1050
• Version / Model: 1
• Catalog Number: GLL105
• Company Name: Genesys Orthopedics Systems LLC
• Labeler DUNS: 017921066
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-30
• Public Version: 1
• Public Version Date: 2024-11-07
• Public Version Status: New
• Public Device Record Key: 8c9f4f2d-a57a-4d08-a40b-379506af7750

Device Description

Modular Hudson Connect T-Handle

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: 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
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	888.3080	2
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	888.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48165	Lumbar total intervertebral disc prosthesis	An implantable device designed to replace a dysfunctional intervertebral disc in the lumbar spine. It most commonly has a two-plate design, one plate attaching to the vertebra above and the other to the vertebra below and may have a compressible core component between. It may facilitate some degree of motion and is typically made of metal and/or synthetic polymer materials. This is the complete prosthesis assembly, not individual components.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M719GLL1050	HIBCC

Customer Contacts

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