AccessGUDID - DEVICE: 45mm Stock TMJ Condylar Prosthesis (LEFT SIDE and RIGHT SIDE) (M9575000900)

GUDID

Device Identifier (DI) Information

Brand Name: 45mm Stock TMJ Condylar Prosthesis (LEFT SIDE and RIGHT SIDE)
Version or Model: 500090
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Nexus Cmf, L.L.C.

Primary DI Number: M9575000900
Issuing Agency: HIBCC
Commercial Distribution End Date: May 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 965540227 *Terms of Use

Device Description: 45mm Stock TMJ Condylar Prosthesis (LEFT SIDE and RIGHT SIDE)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LZD	Joint, Temporomandibular, Implant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 759ba3a8-08c7-4416-bfa3-1916ecbccf19
Public Version Date: June 09, 2025
Public Version Number: 6
DI Record Publish Date: November 11, 2014