Infinity OCT System, PASS OCT® Spinal System
K-Number: K210449 · 2021-03-18
ApplicantMedtronic
Decision Date2021-03-18
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Infinity OCT System, PASS OCT® Spinal System is a medical device manufactured by Medtronic. It received FDA 510(k) clearance on 2021-03-18 under approval number K210449. 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, PASS OCT® Spinal System?
Infinity OCT System, PASS OCT® Spinal System is a medical device that received FDA 510(k) clearance on 2021-03-18. It is manufactured by Medtronic. The 510(k) number is K210449.
When was Infinity OCT System, PASS OCT® Spinal System approved by the FDA?
Infinity OCT System, PASS OCT® Spinal System received FDA 510(k) clearance on 2021-03-18, under approval number K210449.
What company makes Infinity OCT System, PASS OCT® Spinal System?
Infinity OCT System, PASS OCT® Spinal System is manufactured by Medtronic.
What is the FDA product code for Infinity OCT System, PASS OCT® Spinal System?
The FDA product code for Infinity OCT System, PASS OCT® Spinal System is NKG.
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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.