FIXIT EPA9000004

GUDID 03760154003513

Surgical Instrument Set consisting of reusable surgical instruments intended to be used during arthroscopic implantation of the FIXIT implant for rotator cuff repair (1st + 2nd rows) with automatic grasper.

S.B.M

Arthroscopic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03760154003513
• NIH Device Record Key: c7595f81-435e-40de-a116-fc21676e46ca
• Commercial Distribution Discontinuation: 2024-06-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: FIXIT
• Version Model Number: Complete FIXIT basket 1st + 2nd rows with automati
• Catalog Number: EPA9000004
• Company DUNS: 772462123
• Company Name: S.B.M
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	03760154003513 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[03760154003513]

Moist Heat or Steam Sterilization

[03760154003513]

Moist Heat or Steam Sterilization

[03760154003513]

Moist Heat or Steam Sterilization

[03760154003513]

Moist Heat or Steam Sterilization

[03760154003513]

Moist Heat or Steam Sterilization

[03760154003513]

Moist Heat or Steam Sterilization

[03760154003513]

Moist Heat or Steam Sterilization

[03760154003513]

Moist Heat or Steam Sterilization

[03760154003513]

Moist Heat or Steam Sterilization

[03760154003513]

Moist Heat or Steam Sterilization

[03760154003513]

Moist Heat or Steam Sterilization

[03760154003513]

Moist Heat or Steam Sterilization

[03760154003513]

Moist Heat or Steam Sterilization

[03760154003513]

Moist Heat or Steam Sterilization

[03760154003513]

Moist Heat or Steam Sterilization

[03760154003513]

Moist Heat or Steam Sterilization

[03760154003513]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-20
• Device Publish Date: 2024-06-12

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