Integrity Implant Fixation Kit

GUDID M06760001020

Integrity Tissue Tacks and Integrity Bone Staples packaged in a Caddy.

Anika Therapeutics, Inc.

Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable

• Primary Device ID: M06760001020
• NIH Device Record Key: 0d4d1512-962a-49e4-be4e-5ed645f3b8fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrity Implant Fixation Kit
• Version Model Number: 6000102
• Company DUNS: 807613393
• Company Name: Anika Therapeutics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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
HIBCC	M06760001020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222487

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-22
• Device Publish Date: 2023-11-14

Devices Manufactured by Anika Therapeutics, Inc.

• 00817337000319 - Deployment Skid Cannula Access Tool: 2024-05-23 Reusable non-rigid cannula access tool
• 08033549791117 - MEROGEL 2pk 4x4cm: 2024-04-26 Merogel is used in the nasal/sinus and the middle ear/external ear canal as a space occupying dressing and/or stent, to separat
• 08033549791124 - MEROGEL 1PK 4x4cm: 2024-04-26 Merogel is used in the nasal/sinus and the middle ear/external ear canal as a space occupying dressing and/or stent, to separat
• M06760001020 - Integrity Implant Fixation Kit: 2023-11-22Integrity Tissue Tacks and Integrity Bone Staples packaged in a Caddy.
• M06760001020 - Integrity Implant Fixation Kit: 2023-11-22 Integrity Tissue Tacks and Integrity Bone Staples packaged in a Caddy.
• M06760001180 - Integrity Delivery Instrument, Bone Staple: 2023-11-22 Integrity bone staple delivery instrument, single-use
• M06760001200 - Integrity Delivery Instrument, Tissue Tack: 2023-11-22 Integrity tissue tack delivery instrument, single use
• 00817337000241 - Integrity Implant: 2023-11-17 Integrity Implant, 20mm x 25mm
• 00817337000258 - Integrity Implant: 2023-11-17 Integrity Implant, 25mmx30mm