Infinity OCT System and PASS OCT Spinal System
K-Number: K220810 · 2022-04-19
ApplicantMedicrea International
Decision Date2022-04-19
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Infinity OCT System and PASS OCT Spinal System is a medical device manufactured by Medicrea International. It received FDA 510(k) clearance on 2022-04-19 under approval number K220810. 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 and PASS OCT Spinal System?
Infinity OCT System and PASS OCT Spinal System is a medical device that received FDA 510(k) clearance on 2022-04-19. It is manufactured by Medicrea International. The 510(k) number is K220810.
When was Infinity OCT System and PASS OCT Spinal System approved by the FDA?
Infinity OCT System and PASS OCT Spinal System received FDA 510(k) clearance on 2022-04-19, under approval number K220810.
What company makes Infinity OCT System and PASS OCT Spinal System?
Infinity OCT System and PASS OCT Spinal System is manufactured by Medicrea International.
What is the FDA product code for Infinity OCT System and PASS OCT Spinal System?
The FDA product code for Infinity OCT System and 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.