Anchor with Fiber Wire and Disposable Inserter
K-Number: K253027 · 2026-05-06
ApplicantOrtobio S.A.
Decision Date2026-05-06
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Anchor with Fiber Wire and Disposable Inserter is a medical device manufactured by Ortobio S.A.. It received FDA 510(k) clearance on 2026-05-06 under approval number K253027. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Anchor with Fiber Wire and Disposable Inserter?
Anchor with Fiber Wire and Disposable Inserter is a medical device that received FDA 510(k) clearance on 2026-05-06. It is manufactured by Ortobio S.A.. The 510(k) number is K253027.
When was Anchor with Fiber Wire and Disposable Inserter approved by the FDA?
Anchor with Fiber Wire and Disposable Inserter received FDA 510(k) clearance on 2026-05-06, under approval number K253027.
What company makes Anchor with Fiber Wire and Disposable Inserter?
Anchor with Fiber Wire and Disposable Inserter is manufactured by Ortobio S.A..
What is the FDA product code for Anchor with Fiber Wire and Disposable Inserter?
The FDA product code for Anchor with Fiber Wire and Disposable Inserter is MBI.
Related Devices (Code: MBI)
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.