INFINITY™ Occipitocervical Upper Thoracic System

FDA UDI

Class II (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: INFINITY™ Occipitocervical Upper Thoracic System FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: MULTI AXIAL SCREW 3603540 3.5 X 40MM FDA UDI
Model / Reference: 3603540 FDA UDI
Description: MULTI AXIAL SCREW 3603540 3.5 X 40MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169554535 FDA UDI
510(k) Number: K163375 FDA UDI
FDA Product Code: KWP FDA UDI
NKG FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
888.3075 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Spinal bone screw, non-bioabsorbable

INFINITY™ Occipitocervical Upper Thoracic System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal bone screw, non-bioabsorbable.

4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II

Cleared under the same submission

K163375 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: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI 54e042ce-1e07-4d39-b577-17d3eedb84fe 36 fields · synced May 30, 2026