HammerFuze

GUDID 00841731106834

HammerFUZE Implant 2.2x18 Str._Ti L.Blue

VILEX IN TENNESSEE, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841731106834
• NIH Device Record Key: e687649f-0911-4a24-9007-54d641aee789
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HammerFuze
• Version Model Number: TH22-18T-0900
• 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	00841731106834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141937

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00841731106834]

Moist Heat or Steam Sterilization

[00841731106834]

Moist Heat or Steam Sterilization

[00841731106834]

Moist Heat or Steam Sterilization

[00841731106834]

Moist Heat or Steam Sterilization

[00841731106834]

Moist Heat or Steam Sterilization

[00841731106834]

Moist Heat or Steam Sterilization

[00841731106834]

Moist Heat or Steam Sterilization

[00841731106834]

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: 2016-08-03

On-Brand Devices [HammerFuze]

• 00841731106889: HammerFUZE Implant 3.0x25 Angled_Ti Magenta
• 00841731106872: HammerFUZE Implant 3.0x25 Str._Ti Magenta
• 00841731106865: HammerFUZE Implant 2.5x20 Angled_Ti Gold
• 00841731106858: HammerFUZE Implant 2.5x20 Str._Ti Gold
• 00841731106841: HammerFUZE Implant 2.2x18 Angled_Ti L.Blue
• 00841731106834: HammerFUZE Implant 2.2x18 Str._Ti L.Blue