Affixus®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: Affixus® FDA UDI
Generic Name: Tibia intramedullary nail FDA UDI
Model / Reference: 815408280 FDA UDI

Identifiers

Catalog Number: 815408280 FDA UDI
Primary DI / UDI-DI: 00887868583582 FDA UDI
510(k) Number: K241651 FDA UDI
FDA Product Code: HWC FDA UDI
HSB FDA UDI
GMDN Term: Tibia intramedullary nail FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
888.3020 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

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Tibia intramedullary nail

Affixus® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tibia intramedullary nail.

TRIGEN MAX — Smith & Nephew, Inc. · Class II
Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD · Class II
AJAX Nail — Auxein Medical Private Limited · Class II
ESTREMO — Citieffe · Class II
PNP Tibia — ORTHOPEDIATRICS CORP. · Class II
PNP Tibia — ORTHOPEDIATRICS CORP. · Class II
DYNAMIC TIBIAL NAIL — Biomet Orthopedics, Inc. · Class II
VERSANAIL®TIBIAL NAIL — Biomet Orthopedics, Inc. · Class II

Cleared under the same submission

K241651 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: Zimmer, Inc.

Sources (1)

FDA UDI 5fc06f84-2861-49eb-b1b5-8d45f9f494b0 36 fields · synced Jun 8, 2026