BT LOOP BTBXL01709

GUDID 03760154008204

The BT LOOP® adjustable cortical fixation device consists of an adjustable nonabsorbable braided loop and titanium button, preloaded with traction, flip threads, and splicing sutures, designed to be used for ACL reconstruction with a bone-tendon-bone graft. The device is presented on a holder, and is supplied sterile, ready to use.

S.B.M

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 03760154008204
• NIH Device Record Key: 62046d4a-572f-4643-8a0d-7707e55ce0e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BT LOOP
• Version Model Number: Adjustable fixation system for ligament reconstruc
• Catalog Number: BTBXL01709
• Company DUNS: 772462123
• Company Name: S.B.M
• 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: 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	03760154008204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202193

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

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: 2023-12-28
• Device Publish Date: 2023-12-20

On-Brand Devices [BT LOOP]

• 03760154008204: The BT LOOP® adjustable cortical fixation device consists of an adjustable nonabsorbable braide
• 03760154008198: The BT LOOP® adjustable cortical fixation device consists of an adjustable nonabsorbable braide