Patient-Specific TMJ Condylar Prosthesis (LEFT SIDE)

Basic Information

• Brand Name: Patient-Specific TMJ Condylar Prosthesis (LEFT SIDE)
• Primary DI: M9575001090
• Version / Model: 500109
• Company Name: Nexus Cmf, L.L.C.
• Labeler DUNS: 965540227
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-10-15
• Public Version: 6
• Public Version Date: 2025-06-09
• Public Version Status: Update
• Public Device Record Key: 33ee1d7f-2df8-412e-bcf1-6b4bc4bade1c
• Distribution End Date: 2017-05-31

Device Description

Patient-Specific TMJ Condylar Prosthesis (LEFT SIDE)

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
LZD	Joint, Temporomandibular, Implant	Dental	872.3940	3

GMDN Terms

Code	Name	Definition	Implantable	Status
35943	Mandibular condyle prosthesis	An implantable device designed to permanently replace the natural mandibular condylar head, providing an articulation with the mandibular fossa and a partial substitution of the temporomandibular joint articulation. It is typically made of a combination of a metal frame and plastic (e.g., polymethylmethacrylate) or a combination of metal and polymeric materials. The device is typically used in combination with mandibular fossa components in total temporomandibular joint (TMJ) prostheses.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M9575001090	HIBCC