Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
K-Number: K251315 · 2025-05-29
ApplicantRemex Medical Corp.
Decision Date2025-05-29
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II is a medical device manufactured by Remex Medical Corp.. It received FDA 510(k) clearance on 2025-05-29 under approval number K251315. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II?
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II is a medical device that received FDA 510(k) clearance on 2025-05-29. It is manufactured by Remex Medical Corp.. The 510(k) number is K251315.
When was Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II approved by the FDA?
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II received FDA 510(k) clearance on 2025-05-29, under approval number K251315.
What company makes Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II?
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II is manufactured by Remex Medical Corp..
What is the FDA product code for Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II?
The FDA product code for Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II is OLO.
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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.