Orthex

GUDID 00841731112316

Rod, Threaded M4 30mm

VILEX IN TENNESSEE, INC.

External orthopaedic fixation system, single-use, non-sterile

• Primary Device ID: 00841731112316
• NIH Device Record Key: e4e5cfbc-edfc-48f9-b93d-291cd42bc740
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthex
• Version Model Number: C450-04-30
• 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	00841731112316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151881

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

[00841731112316]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2020-07-02
• Device Publish Date: 2016-09-30

On-Brand Devices [Orthex]

• 00841731121172: Orthex SB Nut, Thick, 7mm
• 00841731119865: Orthex Strut Quick Locking 135mm
• 00841731119858: Orthex Strut Quick Locking 95mm
• 00841731119834: Orthex Pin Cube 6-hole, LB, Ti
• 00841731119667: Wrench, SB 90 cannulated
• 00841731119209: Orthex P&C Software
• 00841731119193: Orthex 5/8 Ring 230mm
• 00841731119179: Orthex Pin Cube 5 hole SB, Ti
• 00841731119162: Orthex Pin Cube Quad SB, Ti
• 00841731119155: Orthex Pin Cube Triple SB, Ti
• 00841731119148: Orthex Pin Cube Double SB, Ti
• 00841731119131: Orthex Pin Cube Single SB, Ti
• 00841731119117: Socket, Threaded SB 40mm
• 00841731119100: Hinge, Universal SB
• 00841731119087: Nut, Thrd Coupling 18mm
• 00841731118707: Orthex Pin Cube 6 hole SB, Ti
• 00841731118349: Orthex Full Ring 230mm
• 00841731115836: Bolt, 08mm
• 00841731115812: Orthex Z-Plate SB 35mm, Ti
• 00841731115805: Orthex Z-Plate SB 35mm, Long, Ti
• 00841731115799: Orthex 50mm Z-Plate, Ti
• 00841731115782: Orthex 50mm Z-Plate, Long, Ti
• 00841731115775: Orthex Pin Cube Quin LB, Ti
• 00841731115768: Orthex Pin Cube Quad LB, Ti
• 00841731115751: Orthex Pin Cube Trpl LB, Ti
• 00841731115744: Orthex Pin Cube Dbl LB, Ti
• 00841731115737: Orthex Pin Cube Sgl LB, Ti
• 00841731115720: Orthex FootPlate 180mm Short
• 00841731115713: Orthex FootPlate 155mm Short
• 00841731115706: Orthex FootPlate 130mm Short
• 00841731115690: Orthex Full Ring 205mm
• 00841731115645: Orthex, Strut Telescoping SB 55-80
• 00841731115638: Orthex SB Number Clip #6 VIOLET
• 00841731115621: Orthex SB Number Clip #5 BLUE
• 00841731115614: Orthex SB Number Clip #4 GREEN
• 00841731115607: Orthex SB Number Clip #3 GOLD
• 00841731115591: Orthex SB Number Clip #2 ORANGE
• 00841731115584: Orthex SB Number Clip #1 RED
• 00841731115577: Orthex SB Shoulder Bolt
• 00841731115560: Orthex, Bolt, Shoulder MS Strut
• 00841731115553: Orthex Indicator Cap Strut, Purple
• 00841731115546: Orthex Indicator Cap Strut, Dark Blue
• 00841731115539: Orthex Indicator Cap Strut, Bright Green
• 00841731115522: Orthex Indicator Cap Strut, Yellow
• 00841731115515: Orthex Indicator Cap Strut, Orange
• 00841731115508: Orthex Indicator Cap Strut, Red
• 00841731115492: Wire Pear Sharp Bayonet 370x1.8mm HA Sterile
• 00841731115485: Wire Sharp Bayonet Olive 1.8x370mm
• 00841731115478: Wire Sharp Bayonet 1.8x370mm
• 00841731115461: Wire Sharp Bayonet Olive 1.5x300mm HA Sterile