Navigated INFINITY™ Instruments

by Medtronic Sofamor Danek USA, Inc.

510(k) K173338

Navigated INFINITY™ Instruments is a Class II device made by Medtronic Sofamor Danek USA, Inc., cleared under FDA 510(k) K173338 on 18 Jan 2018, active as of 26 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

510(k) K173338↗

FDA record

Trust

Source FDA 510(k), synced 26 Oct 2026.

Regulatory status

as of registry sync 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK173338	Date18 Jan 2018Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K173338

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K173338
FDA product code: OLO

Device class: Class II
Regulation: 21 CFR Part 882.4560
Advisory committee: Neurology
FDA decision: SESE Substantially Equivalent

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