PASS OCT Spinal System
K-Number: K161149 · 2016-07-11
ApplicantMedicrea International SA
Decision Date2016-07-11
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
PASS OCT Spinal System is a medical device manufactured by Medicrea International SA. It received FDA 510(k) clearance on 2016-07-11 under approval number K161149. 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 PASS OCT Spinal System?
PASS OCT Spinal System is a medical device that received FDA 510(k) clearance on 2016-07-11. It is manufactured by Medicrea International SA. The 510(k) number is K161149.
When was PASS OCT Spinal System approved by the FDA?
PASS OCT Spinal System received FDA 510(k) clearance on 2016-07-11, under approval number K161149.
What company makes PASS OCT Spinal System?
PASS OCT Spinal System is manufactured by Medicrea International SA.
What is the FDA product code for PASS OCT Spinal System?
The FDA product code for 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.