Affixus®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: Affixus® FDA UDI
Generic Name: Orthopaedic instrument surgical connector FDA UDI
Model / Reference: 211304015 FDA UDI

Identifiers

Catalog Number: 211304015 FDA UDI
Primary DI / UDI-DI: 00887868582417 FDA UDI
510(k) Number: K241651 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Orthopaedic instrument surgical connector FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Orthopaedic instrument surgical connector

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

Similar devices

Also classified as Orthopaedic instrument surgical connector.

Surgical Instrument — Jeil Medical Corporation · Class I
Maxim® Instrumentation — Biomet Orthopedics, Inc. · Class I
QUANTUM — IN2BONES · Class I
KINCISE™ System Acetabular Cup Extraction SST Head 28mm — Spierings Orthopaedics B.V. · Class I
Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
Pilot Spinal System — Life Spine, Inc. · Class II
MIS Curved Rod, Ø5.5 x 85mm — Captiva Spine · 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 949aa398-7f2e-4cf9-9332-f7fc7ca4a98d 35 fields · synced Jun 1, 2026