Twinfix

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: TWINFIX FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: TWINFIX ULTRA 5.5 MM PK SUTURE ANCHOR WITH TWO No.2 ULTRABRAID SUTURES BLUE, BLUE-COBRAID WITH NEEDLES FDA UDI
Model / Reference: 72202615 FDA UDI
Description: TWINFIX ULTRA 5.5 MM PK SUTURE ANCHOR WITH TWO No.2 ULTRABRAID SUTURES BLUE, BLUE-COBRAID WITH NEEDLES FDA UDI

Identifiers

Catalog Number: 72202615 FDA UDI
Primary DI / UDI-DI: 03596010656209 FDA UDI
FDA Product Code: MBI FDA UDI
GMDN Term: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 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

Category: Tendon/ligament bone anchor, non-bioabsorbable

Twinfix by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
JuggerKnot Soft Anchors — Biomet Orthopedics, 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: Smith & Nephew, Inc.

Sources (1)

FDA UDI 11223e0d-bf13-4517-aa73-8a93d687adbf 35 fields · synced Jun 8, 2026