TissueTak™

FDA UDI

Class II (US FDA UDI)

by Via Surgical , Ltd.

Identity

Trade Name: TissueTak™ FDA UDI
Generic Name: Soft-tissue/mesh anchor, bioabsorbable FDA UDI
Device Name: TissueTak™ Absorbable Fixation System 10 Absorbable Fasteners Tendon Anchor Device in Rotator Cuff Augmentation Kit FDA UDI
Model / Reference: AR-19021TT-1 FDA UDI
Description: TissueTak™ Absorbable Fixation System 10 Absorbable Fasteners Tendon Anchor Device in Rotator Cuff Augmentation Kit FDA UDI

Identifiers

Catalog Number: AR-19021TT-1 FDA UDI
Primary DI / UDI-DI: 07290017155364 FDA UDI
510(k) Number: K203117 FDA UDI
FDA Product Code: GDW FDA UDI
GMDN Term: Soft-tissue/mesh anchor, bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

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

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 5 Millimeter FDA UDI
Length — 20.9 Centimeter FDA UDI

Category: Soft-tissue/mesh anchor, bioabsorbable

TissueTak™ by Via Surgical , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Mendit Reload Set — Escala Medical · Class II
OPTIFIX — Davol Inc. · Class II
Integrity Implant Fixation Kit — Anika Therapeutics, Inc. · Class II
OPTIFIX — Davol Inc. · Class II
Mendit Reload Set — Escala Medical · Class II
Mendit Reload Set — Escala Medical · Class II
OPTIFIX — Davol Inc. · Class II
Arthrex® — Arthrex, Inc. · Class II

Cleared under the same submission

K203117 also covers:

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: Via Surgical , Ltd.

Sources (1)

FDA UDI cdcb4247-6489-47ee-8ffa-2756ccedda75 37 fields · synced Jun 8, 2026