ComposiTCP™ 110026111

GUDID 03760154008273

Ø4.5 mm suture anchor punch tap

S.B.M

Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable

• Primary Device ID: 03760154008273
• NIH Device Record Key: 09dca3ff-8538-4d7a-9656-f063f69f827f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComposiTCP™
• Version Model Number: Suture Anchor Punch Tap
• Catalog Number: 110026111
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760154008273 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170868

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-12-08
• Device Publish Date: 2018-03-13

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