Tactoset

GUDID 00817337000074

Tactoset is a synthetic, injectable, settable osteoconductive calcium phosphate bone graft substitute material.

Anika Therapeutics, Inc.

Bone matrix implant, synthetic

• Primary Device ID: 00817337000074
• NIH Device Record Key: d09f96d6-abe2-4678-b01e-7c479cc8cb09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tactoset
• Version Model Number: 6000041
• Company DUNS: 807613393
• Company Name: Anika Therapeutics, 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: false
• 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

Customer Support Contacts

• Phone: 7814579000
• Email: customerservice@anikatherapeutics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817337000074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173008

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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: 2019-10-23
• Device Publish Date: 2019-10-15

Devices Manufactured by Anika Therapeutics, Inc.

• 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
• M06760001220 - Integrity Cannula/Obturator Kit: 2023-11-17 Integrity Cannula and Obturator, single-use
• 08033549791063 - Epifilm Otologic: 2022-02-14 Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the na
• 00817337000128 - Ophthalin: 2022-01-06 0.8 ml, 1.2% OVD Sodium Hyaluronate