TopLock TP-AN-3501

GUDID 00840124501331

Threaded Suture Anchor 3.5 mm

FUSION ORTHOPEDICS, LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00840124501331
• NIH Device Record Key: 4a5e18c4-81a2-49b0-87cb-b780cc1cdcbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TopLock
• Version Model Number: TP-AN-3501
• Catalog Number: TP-AN-3501
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• Device Count: 1
• DM Exempt: true
• 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	00840124501331 [Primary]

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

[00840124501331]

Moist Heat or Steam Sterilization

[00840124501331]

Moist Heat or Steam Sterilization

[00840124501331]

Moist Heat or Steam Sterilization

[00840124501331]

Moist Heat or Steam Sterilization

[00840124501331]

Moist Heat or Steam Sterilization

[00840124501331]

Moist Heat or Steam Sterilization

[00840124501331]

Moist Heat or Steam Sterilization

[00840124501331]

Moist Heat or Steam Sterilization

[00840124501331]

Moist Heat or Steam Sterilization

[00840124501331]

Moist Heat or Steam Sterilization

[00840124501331]

Moist Heat or Steam Sterilization

[00840124501331]

Moist Heat or Steam Sterilization

[00840124501331]

Moist Heat or Steam Sterilization

[00840124501331]

Moist Heat or Steam Sterilization

[00840124501331]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-29
• Device Publish Date: 2020-12-21

On-Brand Devices [TopLock]

• 00840124501706: Barbed Tape Anchor 3.5 mm
• 00840124501690: Barbed Suture Anchor 3.5 mm
• 00840124501683: Threaded Tape Anchor 3.5 mm
• 00840124501676: Threaded Suture Anchor 3.5 mm
• 00840124501669: Knotless Tape Anchor 3.8 mm
• 00840124501652: Knotless Suture Anchor 3.8 mm
• 00840124501645: Knotless Tape Anchor 4.5 mm
• 00840124501638: Knotless Suture Anchor 4.5 mm
• 00840124501621: Knotless Tape Anchor 5.0 mm
• 00840124501614: Knotless Suture Anchor 5.0 mm
• 00840124501607: Suture Threader
• 00840124501591: Threaded Anchor Inserter 3.5 mm
• 00840124501584: Barbed Anchor Inserter 3.5 mm
• 00840124501577: Locking Anchor Inserter
• 00840124501560: Anchor Adjustment Tool 4.5 mm & 3.8 mm
• 00840124501553: Anchor Adjustment Tool 5.0 mm
• 00840124501546: Punch 2.1 mm Long
• 00840124501539: Punch 3.0 mm Long
• 00840124501522: Punch 3.5 mm Long
• 00840124501515: Punch 4.6 mm Long
• 00840124501508: Punch 2.1 mm Short
• 00840124501492: Punch 3.0 mm Short
• 00840124501485: Punch 3.5 mm Short
• 00840124501478: Punch 4.6 mm Short
• 00840124501461: Drill Solid 1.7 mm
• 00840124501454: Drill Solid 2.3 mm
• 00840124501447: Drill Solid 2.6 mm
• 00840124501430: Drill Solid 3.1 mm
• 00840124501423: Drill Solid 4.2 mm
• 00840124501416: Drill Guide 3.5 mm Barbed
• 00840124501409: Drill Guide 3.5 mm Threaded
• 00840124501393: Drill Guide 3.8 mm
• 00840124501386: Drill Guide 4.5 mm
• 00840124501379: Drill Guide 5.0 mm
• 00840124501362: Barbed Tape Anchor 3.5 mm
• 00840124501355: Barbed Suture Anchor 3.5 mm
• 00840124501348: Threaded Tape Anchor 3.5 mm
• 00840124501331: Threaded Suture Anchor 3.5 mm
• 00840124501324: Knotless Tape Anchor 3.8 mm
• 00840124501317: Knotless Suture Anchor 3.8 mm
• 00840124501300: Knotless Tape Anchor 4.5 mm
• 00840124501294: Knotless Suture Anchor 4.5 mm
• 00840124501287: Knotless Tape Anchor 5.0 mm
• 00840124501270: Knotless Suture Anchor 5.0 mm
• 00840124511712: 4.75mm Knotted Anchor Instrument Kit
• 00840124511705: 3.5mm Knotted Anchor Instrument Kit
• 00840124511699: 4.75mm Knotless Anchor Instrument Kit
• 00840124511682: 3.5mm Knotless Anchor Instrument Kit
• 00840124511675: 4.75mm Knotted Anchor Implant Kit
• 00840124511668: 3.5mm Knotted Anchor Implant Kit