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OSSIO , Ltd. FDA Approvals

0 new drug approvals and 16 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
OSSIOfiber® Threaded Trimmable Fixation Nail510(k)May 1, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 1, 2026
OSSIOfiber® Suture Anchor510(k)Feb 24, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 24, 2026
OSSIOfiber® Interference Screw510(k)Aug 19, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 19, 2025
OSSIOfiber® Suture Anchor510(k)May 27, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	May 27, 2025
OSSIOfiber® Suture Anchor 2.5-3.5 mm510(k)Apr 3, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 3, 2025
OSSIOfiber® Compression Staple510(k)Aug 28, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 28, 2024
OSSIOfiber® Threaded Trimmable Fixation Nail510(k)Jul 3, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 3, 2024
OSSIOfiber® Threaded Trimmable Fixation Nails510(k)Mar 8, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 8, 2024
OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail510(k)Dec 1, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 1, 2023
OSSIOfiber® Compression Staple510(k)Nov 16, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 16, 2023
OSSIOfiber® Cannulated Trimmable Fixation Nail510(k)Sep 13, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 13, 2023
OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm510(k)Dec 23, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 23, 2022
OSSIOfiber Suture Anchor510(k)Mar 28, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 28, 2022
OSSIOfiber® Staple510(k)Jan 21, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 21, 2022
OSSIOfiber Compression Screw, 3.5mm510(k)Dec 21, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 21, 2021
OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design510(k)Jan 6, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 6, 2021

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