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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
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
DOMINO 3601475 OFFSET 3.5 TO 4.75MM FDA UDI
Model / Reference
3601475 FDA UDI
Description
DOMINO 3601475 OFFSET 3.5 TO 4.75MM FDA UDI

Identifiers

Primary DI / UDI-DI
00643169527775 FDA UDI
510(k) Number
K163375 FDA UDI
FDA Product Code
KWP FDA UDI
NKG FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Bone-screw internal spinal fixation system connector

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 Bone-screw internal spinal fixation system connector.

Cleared under the same submission

K163375 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Sofamor Danek, Inc.

Sources (1)

  • FDA UDI 92c6c3a8-3dfb-4e98-bfc6-6689e33f70a3 36 fields · synced May 29, 2026