2.0x6.0mm [1] & 2.0x8.0mm [4] Screws

GUDID M9575001110

2.0x6.0mm [1] & 2.0x8.0mm [4] Screws

Nexus Cmf, LLC

Craniofacial bone screw, non-bioabsorbable, sterile

• Primary Device ID: M9575001110
• NIH Device Record Key: 9eb11e88-703c-4be2-bea7-395a49796451
• Commercial Distribution Discontinuation: 2017-05-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 2.0x6.0mm [1] & 2.0x8.0mm [4] Screws
• Version Model Number: 500111
• Company DUNS: 965559623
• Company Name: Nexus Cmf, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M9575001110 [Primary]

FDA Product Code

• MPI: Glenoid Fossa Prosthesis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-10-19
• Device Publish Date: 2016-09-02

Devices Manufactured by Nexus Cmf, LLC

• M9575000010 - Stock TMJ Fossa-Eminence Prosthesis (LEFT 01): 2020-10-27 Stock TMJ Fossa-Eminence Prosthesis (LEFT 01)
• M9575000030 - Stock TMJ Fossa-Eminence Prosthesis (LEFT 03): 2020-10-27 Stock TMJ Fossa-Eminence Prosthesis (LEFT 03)
• M9575000040 - Stock TMJ Fossa-Eminence Prosthesis (LEFT 04): 2020-10-27 Stock TMJ Fossa-Eminence Prosthesis (LEFT 04)
• M9575000050 - Stock TMJ Fossa-Eminence Prosthesis (LEFT 05): 2020-10-27 Stock TMJ Fossa-Eminence Prosthesis (LEFT 05)
• M9575000060 - Stock TMJ Fossa-Eminence Prosthesis (LEFT 06): 2020-10-27 Stock TMJ Fossa-Eminence Prosthesis (LEFT 06)
• M9575000080 - Stock TMJ Fossa-Eminence Prosthesis (LEFT 08): 2020-10-27 Stock TMJ Fossa-Eminence Prosthesis (LEFT 08)
• M9575000100 - Stock TMJ Fossa-Eminence Prosthesis (LEFT 10): 2020-10-27 Stock TMJ Fossa-Eminence Prosthesis (LEFT 10)
• M9575000130 - Stock TMJ Fossa-Eminence Prosthesis (LEFT 13): 2020-10-27 Stock TMJ Fossa-Eminence Prosthesis (LEFT 13)