Screw System TX BTX00

GUDID E0HM79BTX001

Screw system for fixation of bone segments e.g. for horizontal or vertical augmentative grafts The kit includes dental screws TX and neccessary accessories. The bone screws have a self-tapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force. Dental Bone Screws are delivered non sterile. The following screws are included: 7pcs TCT09 007, 7pcs TCT09 010, 3pcs TCT10 007, 3pcs TCT10 010

Hager & Meisinger Gesellschaft mit beschränkter Haftung

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: E0HM79BTX001
• NIH Device Record Key: bb11130a-10dd-478f-85d6-3a9e9b4369dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Screw System TX
• Version Model Number: BTX00
• Catalog Number: BTX00
• Company DUNS: 318034329
• Company Name: Hager & Meisinger Gesellschaft mit beschränkter Haftung
• 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: true
• 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

Customer Support Contacts

• Phone: +1 (303) 268-5400
• Email: info@meisingerusa.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E0HM79BTX001 [Primary]
HIBCC	E0HM79BTX009 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132212

FDA Product Code

• DZL: Screw, Fixation, Intraosseous

Sterilization

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

[E0HM79BTX001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-15
• Device Publish Date: 2015-07-10

Devices Manufactured by Hager & Meisinger Gesellschaft mit beschränkter Haftung

• E0HM2449LKR317012101 - Bone Management: 2025-03-24 HARTMETALLFIN. - FG
• E0HM36GF0800622801 - n/a: 2025-03-24 Surgical Guide Fixation Screw
• E0HM39BMP0000161 - Bone Management: 2025-03-24 Screwdriver T6 L76.1
• E0HM39BMP0000171 - Bone Management: 2025-03-24 Screwdriver T6 L56.1
• E0HM510833L317018101 - Bone Management: 2025-03-24 DIAMANTINSTR. - FG
• E0HM7100001204005101 - n/a: 2025-03-24 HARTMETALLBO. - W myone
• E0HM7100001204006101 - n/a: 2025-03-24 HARTMETALLBO. - W myone
• E0HM7100001204008101 - n/a: 2025-03-24 HARTMETALLBO. - W myone