Traufix osteosynthesis, osteotomy, and arthrodesis devices 061.45

GUDID 07506494208067

6.5mm cancellous screw 32mm thread 45mm

Fixier, S.A. de C.V.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 07506494208067
• NIH Device Record Key: eb89b4dc-8fa5-4975-96a6-ad90c558d9d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Traufix osteosynthesis, osteotomy, and arthrodesis devices
• Version Model Number: 061.45
• Catalog Number: 061.45
• Company DUNS: 951561048
• Company Name: Fixier, S.A. de C.V.
• 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: true
• 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

Customer Support Contacts

• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx
• Phone: +524196881191
• Email: internationalsales@fixier.com.mx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07506494208067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201510

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

[07506494208067]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-30
• Device Publish Date: 2022-09-22

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