TotalTi ACDF by SAGICO
K-Number: K233191 · 2023-11-21
Decision Date2023-11-21
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TotalTi ACDF by SAGICO is a medical device manufactured by Spinal Analytics & Geometrical Implant Co, LLC. It received FDA 510(k) clearance on 2023-11-21 under approval number K233191. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TotalTi ACDF by SAGICO?
TotalTi ACDF by SAGICO is a medical device that received FDA 510(k) clearance on 2023-11-21. It is manufactured by Spinal Analytics & Geometrical Implant Co, LLC. The 510(k) number is K233191.
When was TotalTi ACDF by SAGICO approved by the FDA?
TotalTi ACDF by SAGICO received FDA 510(k) clearance on 2023-11-21, under approval number K233191.
What company makes TotalTi ACDF by SAGICO?
TotalTi ACDF by SAGICO is manufactured by Spinal Analytics & Geometrical Implant Co, LLC.
What is the FDA product code for TotalTi ACDF by SAGICO?
The FDA product code for TotalTi ACDF by SAGICO is OVE.
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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.