Optifix

FDA UDI

Class II (US FDA UDI)

by Davol Inc.

Identity

Trade Name: OPTIFIX FDA UDI
Generic Name: Soft-tissue/mesh anchor, bioabsorbable FDA UDI
Device Name: OptiFix AT Absorbable Fixation System with Articulating Technology, 37 cm length, 5 mm diameter, 15 Fasteners FDA UDI
Model / Reference: 0113315 FDA UDI
Description: OptiFix AT Absorbable Fixation System with Articulating Technology, 37 cm length, 5 mm diameter, 15 Fasteners FDA UDI

Identifiers

Catalog Number: 0113315 FDA UDI
Primary DI / UDI-DI: 00801741136559 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

Dimensions & Sizes

Size: Length — 37 Centimeter FDA UDI
Outer Diameter — 5 Millimeter FDA UDI

Category: Soft-tissue/mesh anchor, bioabsorbable

Optifix by Davol Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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Integrity Implant Fixation Kit — Anika Therapeutics, Inc. · Class II
Mendit Reload Set — Escala Medical · Class II
Mendit Reload Set — Escala Medical · Class II
TissueTak™ — Via Surgical , Ltd. · Class II
Arthrex® — Arthrex, Inc. · Class II
FasTouch™ Absorbable — Via Surgical , Ltd. · Class II
APYX Applicator Set — Escala Medical · 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: Davol Inc.

Sources (1)

FDA UDI 7b881889-8149-4bb8-853d-909e4ba56255 36 fields · synced Jun 1, 2026