FUZE FTZ50-90TH

GUDID 00841731120632

Screw, FUZE 5.0x090mm_Ti Hexalobe Teal

VILEX IN TENNESSEE, INC.

Tibia nail, non-sterile Tibia nail, non-sterile Tibia nail, non-sterile Tibia nail, non-sterile Tibia nail, non-sterile Tibia nail, non-sterile Tibia nail, non-sterile

• Primary Device ID: 00841731120632
• NIH Device Record Key: 8f7ae112-a5ce-4533-a30d-3eb5086f8d9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUZE
• Version Model Number: FTZ50-90TH
• Catalog Number: FTZ50-90TH
• 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	00841731120632 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102413

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[00841731120632]

Moist Heat or Steam Sterilization

[00841731120632]

Moist Heat or Steam Sterilization

[00841731120632]

Moist Heat or Steam Sterilization

[00841731120632]

Moist Heat or Steam Sterilization

[00841731120632]

Moist Heat or Steam Sterilization

[00841731120632]

Moist Heat or Steam Sterilization

[00841731120632]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-30
• Device Publish Date: 2018-07-30

On-Brand Devices [FUZE]

• 00841731120717: FUZE End Cap Ti, Hexalobe
• 00841731120649: Screw, FUZE 5.0x095mm_Ti Hexalobe Teal
• 00841731120632: Screw, FUZE 5.0x090mm_Ti Hexalobe Teal
• 00841731120625: Screw, FUZE 5.0x085mm_Ti Hexalobe Teal
• 00841731120618: Screw, FUZE 5.0x080mm_Ti Hexalobe Teal
• 00841731120601: Screw, FUZE 5.0x075mm_Ti Hexalobe Teal
• 00841731120595: Screw, FUZE 5.0x070mm_Ti Hexalobe Teal
• 00841731120458: Screw, FUZE 5.0x065mm_Ti Hexalobe Teal
• 00841731120434: Screw, FUZE 5.0x060mm_Ti Hexalobe Teal
• 00841731120427: Screw, FUZE 5.0x055mm_Ti Hexalobe Teal
• 00841731120410: Screw, FUZE 5.0x050mm_Ti Hexalobe Teal
• 00841731120403: Screw, FUZE 5.0x045mm_Ti HexalobeTeal
• 00841731120397: Screw, FUZE 5.0x040mm_Ti HexalobeTeal
• 00841731120380: Screw, FUZE 5.0x035mm_Ti Hexalobe Teal
• 00841731120267: Screw, FUZE 5.0x030mm_Ti Hexalobe Teal
• 00841731120229: Screw, FUZE 5.0x025mm_Ti Hexalobe Teal
• 00841731119995: Screw, FUZE 5.0x020mm_Ti Hexalobe Teal
• 00841731119988: Screw, FUZE 5.0x100mm_Ti Hexalobe Teal
• 00841731115683: Reamer, FUZE Canal 12.5mm QC
• 00841731115676: Reamer, FUZE Canal 10.5mm QC
• 00841731115669: Reamer, FUZE Canal 08.0mm QC
• 00841731115652: Reamer, FUZE Canal 08.0mm
• 00841731115386: Guidewire FUZE 2.5x500mm Sgl Trocar
• 00841731115096: FUZE End Cap Ti
• 00841731107312: FUZE, 14.0x250mm_Ti Gray
• 00841731107305: FUZE, 14.0x200mm_Ti Gray
• 00841731107299: FUZE, 14.0x150mm_Ti Gray
• 00841731107282: FUZE, 12.0x250mm_Ti Gray
• 00841731107275: FUZE, 12.0x200mm_Ti Gray
• 00841731107268: FUZE, 12.0x150mm_Ti Gray
• 00841731107251: Screw, FUZE 5.0x095mm_Ti L.Blue
• 00841731107244: Screw, FUZE 5.0x090mm_Ti L.Blue
• 00841731107237: Screw, FUZE 5.0x085mm_Ti L.Blue
• 00841731107220: Screw, FUZE 5.0x080mm_Ti L.Blue
• 00841731107213: Screw, FUZE 5.0x075mm_Ti L.Blue
• 00841731107206: Screw, FUZE 5.0x070mm_Ti L.Blue
• 00841731107190: Screw, FUZE 5.0x065mm_Ti L.Blue
• 00841731107183: Screw, FUZE 5.0x060mm_Ti L.Blue
• 00841731107176: Screw, FUZE 5.0x055mm_Ti L.Blue
• 00841731107169: Screw, FUZE 5.0x050mm_Ti L.Blue
• 00841731107152: Screw, FUZE 5.0x045mm_Ti L.Blue
• 00841731107145: Screw, FUZE 5.0x040mm_Ti L.Blue
• 00841731107138: Screw, FUZE 5.0x035mm_Ti L.Blue
• 00841731107121: Screw, FUZE 5.0x030mm_Ti L.Blue
• 00841731107114: Screw, FUZE 5.0x025mm_Ti L.Blue
• 00841731107107: Screw, FUZE 5.0x020mm_Ti L.Blue
• 00841731107091: Screw, FUZE 5.0x100mm_Ti L.Blue