1st MPJ Met Head Implant

GUDID 00841731106360

Cannulated Metatarsal Hemi Implant 22mm HA Coated

VILEX IN TENNESSEE, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841731106360
• NIH Device Record Key: e3c7602c-96e0-4e67-a452-9a9975a05516
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1st MPJ Met Head Implant
• Version Model Number: CMHI-22
• Company DUNS: 152008371
• Company Name: VILEX IN TENNESSEE, INC.
• 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: false
• 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
GS1	00841731106360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070052

FDA Product Code

• KWD: Prosthesis, Toe, Hemi-, Phalangeal

Sterilization

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

[00841731106360]

Moist Heat or Steam Sterilization

[00841731106360]

Moist Heat or Steam Sterilization

[00841731106360]

Moist Heat or Steam Sterilization

[00841731106360]

Moist Heat or Steam Sterilization

[00841731106360]

Moist Heat or Steam Sterilization

[00841731106360]

Moist Heat or Steam Sterilization

[00841731106360]

Moist Heat or Steam Sterilization

[00841731106360]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-17

On-Brand Devices [1st MPJ Met Head Implant]

• 00841731106360: Cannulated Metatarsal Hemi Implant 22mm HA Coated
• 00841731106353: Cannulated Metatarsal Hemi Implant 20mm HA Coated
• 00841731106346: Cannulated Metatarsal Head Implant 18mm HA Coated
• 00841731106339: Cannulated Metatarsal Head Implant 16mm HA Coated
• 00841731106322: Cannulated Metatarsal Hemi Implant 14mm HA Coated