FIXIT EPABR55CLA

GUDID 03760304680991

FIXIT® Band Ø 5.5 mm threaded anchor mounted on screwdriver

S.B.M

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 03760304680991
• NIH Device Record Key: 85b334d5-54af-459d-8c7a-970ba38facc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIXIT
• Version Model Number: Threaded anchor with tape mounted on screwdriver
• Catalog Number: EPABR55CLA
• Company DUNS: 772462123
• Company Name: S.B.M
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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 Dimensions

• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760304680991 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180960

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, 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: 2023-12-29
• Device Publish Date: 2023-12-21

On-Brand Devices [FIXIT]

• 03760154008921: Knotless threaded anchor for single interference in rotator cuff repair - Ø 6.5 mm, Length 14 m
• 03760154008914: Knotless threaded anchor for single interference in rotator cuff repair - Ø 5.5 mm, Length 14 m
• 03760154008907: Knotless threaded anchor for single interference in rotator cuff repair - Ø 4.5 mm, Length 11.2
• 03760154008884: Threaded anchor system for rotator cuff repair - CLASSIC - Ø 6.5 mm
• 03760154008860: Threaded anchor system for rotator cuff repair - CLASSIC - Ø 5.5 mm
• 03760154008846: Threaded anchor system for rotator cuff repair - CLASSIC - Ø 4.7 mm
• 03760154008853: FIXIT Ø 5.5 mm threaded anchor mounted on screwdriver
• 03760304681004: FIXIT® Band Ø 6.5 mm threaded anchor mounted on screwdriver
• 03760304680991: FIXIT® Band Ø 5.5 mm threaded anchor mounted on screwdriver
• 03760304680984: FIXIT® Band Ø 4.5 mm threaded anchor mounted on screwdriver
• 03760154003353: Reusable suture retriever pin, to be used with FIXIT suture anchors for rotator cuff repair.
• 03760154003520: Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a
• 03760154003513: Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a
• 03760154003391: Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a
• 03760154003384: Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a