Integrity Implant Fixation Kit

FDA UDI

Class II (US FDA UDI)

by Anika Therapeutics, Inc.

Identity

Trade Name: Integrity Implant Fixation Kit FDA UDI
Generic Name: Soft-tissue/mesh anchor, bioabsorbable FDA UDI
Device Name: Integrity Tissue Tacks and Integrity Bone Staples packaged in a Caddy. FDA UDI
Model / Reference: 6000102 FDA UDI
Description: Integrity Tissue Tacks and Integrity Bone Staples packaged in a Caddy. FDA UDI

Identifiers

Primary DI / UDI-DI: M06760001020 FDA UDI
510(k) Number: K222487 FDA UDI
K223860 FDA UDI
FDA Product Code: MBI FDA UDI
GDW FDA UDI
GMDN Term: Soft-tissue/mesh anchor, bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
878.4750 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable Soft-tissue/mesh anchor, bioabsorbable

Integrity Implant Fixation Kit by Anika Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Soft-tissue/mesh anchor, bioabsorbable.

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TissueTak™ — Via Surgical , Ltd. · Class II
Arthrex® — Arthrex, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Anika Therapeutics, Inc.

Sources (1)

FDA UDI 0d4d1512-962a-49e4-be4e-5ed645f3b8fd 34 fields · synced Jun 9, 2026