EXPERT - Flexible Joint Fixation System 312-14-07-S

GUDID 07899258663760

EXPERT ACL TIBIA - Concave Button 14mm /7mm

GM DOS REIS INDUSTRIA E COMERCIO LTDA

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 07899258663760
• NIH Device Record Key: b2d545a7-7fe9-4804-b3bc-a9e179ffa666
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPERT - Flexible Joint Fixation System
• Version Model Number: EXPERT ACL TIBIA - Concave Button 14mm /7mm
• Catalog Number: 312-14-07-S
• Company DUNS: 900865213
• Company Name: GM DOS REIS INDUSTRIA E COMERCIO LTDA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• 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	07899258663760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242311

FDA Product Code

• HTN: Washer, Bolt Nut

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-13
• Device Publish Date: 2024-11-05

On-Brand Devices [EXPERT - Flexible Joint Fixation System]

• 07899258663869: EXPERT FAST DUAL - Dual Flexible Knotless Fixator for Syndesmosis with Inserter
• 07899258663852: Support Plate for Expert ACL
• 07899258663845: EXPERT ACL TIBIAL TAPE - Flexible ACL Tibial Knotless Fixator with adjustable tape – concave b
• 07899258663838: EXPERT ACL TIBIAL TAPE - Flexible ACL Tibial Knotless Fixator with adjustable tape – concave b
• 07899258663821: EXPERT ACL TIBIAL TAPE - Flexible ACL Tibial Knotless Fixator with adjustable tape – concave b
• 07899258663814: EXPERT ACL II with augmentation - Flexible ACL II Knotless Fixator with adjustable tape and liga
• 07899258663807: EXPERT ACL II – Flexible ACL II Knotless Fixator with adjustable tape
• 07899258663791: EXPERT ACL with augmentation - Flexible ACL Knotless Fixator with adjustable wire and tape for l
• 07899258663784: EXPERT ACL – Flexible ACL Knotless Fixator with adjustable wire
• 07899258663777: EXPERT ACL TIBIA - Concave Button 20mm /9mm
• 07899258663760: EXPERT ACL TIBIA - Concave Button 14mm /7mm
• 07899258663753: EXPERT ACL TIBIA - Concave Button 11mm /4mm
• 07899258663746: EXPERT ACL TIBIA - Flexible ACL Tibial Knotless Fixator with adjustable wire – concave button
• 07899258663739: EXPERT ACL TIBIA - Flexible ACL Tibial Knotless Fixator with adjustable wire – concave button
• 07899258663722: EXPERT ACL TIBIA - Flexible ACL Tibial Knotless Fixator with adjustable wire – concave button
• 07899258662268: EXPERT FAST - CORACOID PLATE - Flexible Knotless Fixator Coracoid Plate with Inserter
• 07899258661933: EXPERT FAST- AC - Flexible Knotless Fixator Acromioclavicular with Inserter
• 07899258661599: EXPERT FAST - SYNDESMOSIS - Flexible Knotless Fixator for Syndesmosis with Inserter