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FDA 510(k)

INFINITY OCT System

K-Number: K223764 · 2023-01-11

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2023-01-11
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INFINITY OCT System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2023-01-11 under approval number K223764. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITY OCT System?

INFINITY OCT System is a medical device that received FDA 510(k) clearance on 2023-01-11. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K223764.

When was INFINITY OCT System approved by the FDA?

INFINITY OCT System received FDA 510(k) clearance on 2023-01-11, under approval number K223764.

What company makes INFINITY OCT System?

INFINITY OCT System is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for INFINITY OCT System?

The FDA product code for INFINITY OCT System is NKG.

Related Clinical Trials

NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT04594993 INFINITY™ With ADAPTIS™ Technology Study ACTIVE_NOT_RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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