INFINITY™ Occipitocervical Upper Thoracic System 3600301

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00643169527454 UDI-DI	Date10 Jul 2021Listed	StatusListed GUDID: in commercial distribution

Recalls

5 recalls · 5 ongoing · FDA

5 recalls, same reason
- Ongoing Z-1409-2023 FDA Class II initiated 16 Feb 2023
- Ongoing Z-1413-2023 FDA Class II initiated 16 Feb 2023
- Ongoing Z-1412-2023 FDA Class II initiated 16 Feb 2023
- Ongoing Z-1411-2023 FDA Class II initiated 16 Feb 2023
- Ongoing Z-1410-2023 FDA Class II initiated 16 Feb 2023
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: INFINITY™ Occipitocervical Upper Thoracic System
Generic Name: Bone-screw internal spinal fixation system connector
Model / Reference: 3600301

Primary DI / UDI-DI: 00643169527454
510(k) Number: K163375
FDA Product Code: NKG, KWP
GMDN Term: Bone-screw internal spinal fixation system connector

Device Class: Class II
Regulation Number: 888.3075, 888.3050
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization
MRI Safety: MR Conditional

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Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number

Other properties (10)

Sterile: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No