TiLink-P SI Joint Fusion System
K-Number: K230857 · 2023-09-25
ApplicantSurGenTec, LLC
Decision Date2023-09-25
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TiLink-P SI Joint Fusion System is a medical device manufactured by SurGenTec, LLC. It received FDA 510(k) clearance on 2023-09-25 under approval number K230857. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TiLink-P SI Joint Fusion System?
TiLink-P SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2023-09-25. It is manufactured by SurGenTec, LLC. The 510(k) number is K230857.
When was TiLink-P SI Joint Fusion System approved by the FDA?
TiLink-P SI Joint Fusion System received FDA 510(k) clearance on 2023-09-25, under approval number K230857.
What company makes TiLink-P SI Joint Fusion System?
TiLink-P SI Joint Fusion System is manufactured by SurGenTec, LLC.
What is the FDA product code for TiLink-P SI Joint Fusion System?
The FDA product code for TiLink-P SI Joint Fusion System is OUR.
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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.