OSSIOfiber® Staple
K-Number: K212594 · 2022-01-21
ApplicantOSSIO , Ltd.
Decision Date2022-01-21
Product CodeMNU
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
OSSIOfiber® Staple is a medical device manufactured by OSSIO , Ltd.. It received FDA 510(k) clearance on 2022-01-21 under approval number K212594. 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® Staple?
OSSIOfiber® Staple is a medical device that received FDA 510(k) clearance on 2022-01-21. It is manufactured by OSSIO , Ltd.. The 510(k) number is K212594.
When was OSSIOfiber® Staple approved by the FDA?
OSSIOfiber® Staple received FDA 510(k) clearance on 2022-01-21, under approval number K212594.
What company makes OSSIOfiber® Staple?
OSSIOfiber® Staple is manufactured by OSSIO , Ltd..
What is the FDA product code for OSSIOfiber® Staple?
The FDA product code for OSSIOfiber® Staple is MNU.
Other Devices by OSSIO , Ltd.
K181180OSSIO Pin Product Family
K201803OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant
K193660OSSIOfiber Compression Screws
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.