ComposiTCP™ 110026110

GUDID 03760154008266

Threaded anchor system Ø 6.5 mm

S.B.M

Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw

• Primary Device ID: 03760154008266
• NIH Device Record Key: 35bc8b26-1839-47aa-ac95-5f0997cbdca7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComposiTCP™
• Version Model Number: Double loaded BroadBand suture anchor
• Catalog Number: 110026110
• 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: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 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
• 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	03760154008266 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-09-20
• Device Publish Date: 2018-08-07

On-Brand Devices [ComposiTCP™]

• 03760154007245: Threaded anchor system Ø 6.5 mm with one Blue non-sliding suture and one White/Green sliding su
• 03760154007238: Threaded anchor system Ø 5.5 mm with one Blue non-sliding suture and one White/Green sliding su
• 03760154007221: Threaded anchor system Ø 4.5 mm with one Blue non-sliding suture and one White/Green sliding su
• 03760154008266: Threaded anchor system Ø 6.5 mm
• 03760154008259: Threaded anchor system Ø 5.5 mm
• 03760154008242: Threaded anchor system Ø 4.5 mm
• 03760154008235: Threaded anchor system for rotator cuff repair - CLASSIC - Ø 6.5 mm
• 03760154008228: Threaded anchor system for rotator cuff repair - CLASSIC - Ø 5.5 mm
• 03760154008211: Threaded anchor system for rotator cuff repair - CLASSIC - Ø 4.5 mm
• 03760154008280: Ø 5.5 mm & Ø 6.5 mm suture anchor punch tap
• 03760154008273: Ø4.5 mm suture anchor punch tap