OSSIOfiber® Compression Staple
K-Number: K241932 · 2024-08-28
ApplicantOSSIO , Ltd.
Decision Date2024-08-28
Product CodeMNU
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
OSSIOfiber® Compression Staple is a medical device manufactured by OSSIO , Ltd.. It received FDA 510(k) clearance on 2024-08-28 under approval number K241932. The device is classified under product code MNU. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OSSIOfiber® Compression Staple?
OSSIOfiber® Compression Staple is a medical device that received FDA 510(k) clearance on 2024-08-28. It is manufactured by OSSIO , Ltd.. The 510(k) number is K241932.
When was OSSIOfiber® Compression Staple approved by the FDA?
OSSIOfiber® Compression Staple received FDA 510(k) clearance on 2024-08-28, under approval number K241932.
What company makes OSSIOfiber® Compression Staple?
OSSIOfiber® Compression Staple is manufactured by OSSIO , Ltd..
What is the FDA product code for OSSIOfiber® Compression Staple?
The FDA product code for OSSIOfiber® Compression Staple is MNU.
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K190652OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant
K213596OSSIOfiber Compression Screw, 3.5mm
K203465OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design
Related Devices (Code: MNU)
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.