Integrity Orthopaedics 901003

GUDID 00860013905934

Tendon Seam™ Instrument Kit - 8 Anchor

Integrity Orthopaedics, Inc

Orthopaedic inorganic implant inserter/extractor, single-use

• Primary Device ID: 00860013905934
• NIH Device Record Key: 2c9e31ce-7718-4aa5-a934-4fda2ae781af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrity Orthopaedics
• Version Model Number: 901003
• Catalog Number: 901003
• Company DUNS: 118804591
• Company Name: Integrity Orthopaedics, Inc
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00860013905934 [Primary]

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-26
• Device Publish Date: 2025-05-16

On-Brand Devices [Integrity Orthopaedics]

• 00860009782228: Integrity Orthopaedics Anchor Array System Kit
• 00860009782211: Integrity Orthopaedics Delivery Instrument, included with Anchor Array System Kit
• 00860013905989: Tendon Seam™ Magazine - 4 Anchor
• 00860013905972: Tendon Seam™ Instrument Kit - 4 Anchor
• 00860013905965: Delivery Instrument, included with Tendon Seam™ Instrument Kit - 4 Anchor
• 00860013905958: Tendon Seam™ Magazine - 4 Anchor, included with Tendon Seam™ Instrument Kit - 4 Anchor
• 00860013905941: Tendon Seam™ Magazine - 8 Anchor
• 00860013905934: Tendon Seam™ Instrument Kit - 8 Anchor
• 00860013905927: Delivery Instrument, included with Tendon Seam™ Instrument Kit - 8 Anchor
• 00860013905910: Tendon Seam™ Magazine - 8 Anchor, included with Tendon Seam™ Instrument Kit - 8 Anchor