Catamaran SI Joint Fusion System
K-Number: K250403 · 2025-03-21
ApplicantTenon Medical
Decision Date2025-03-21
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Catamaran SI Joint Fusion System is a medical device manufactured by Tenon Medical. It received FDA 510(k) clearance on 2025-03-21 under approval number K250403. 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 Catamaran SI Joint Fusion System?
Catamaran SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2025-03-21. It is manufactured by Tenon Medical. The 510(k) number is K250403.
When was Catamaran SI Joint Fusion System approved by the FDA?
Catamaran SI Joint Fusion System received FDA 510(k) clearance on 2025-03-21, under approval number K250403.
What company makes Catamaran SI Joint Fusion System?
Catamaran SI Joint Fusion System is manufactured by Tenon Medical.
What is the FDA product code for Catamaran SI Joint Fusion System?
The FDA product code for Catamaran 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.