In2Bones USA, LLC FDA Approvals

0 new drug approvals and 10 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
CoLink® & CoLag® Non-Sterile Screws510(k)May 30, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	May 30, 2026
NeoSpan® Compression Implant System510(k)May 24, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 24, 2024
IBS-B MIS Beveled Screw System510(k)Jul 27, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 27, 2023
CoLink PCR Plating System510(k)May 27, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 27, 2022
Hercules Syndesmosis Implant System510(k)Mar 31, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 31, 2022
Avenger Radial Head System510(k)Dec 17, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 17, 2021
CoLink NeoFuse Plating System510(k)Dec 13, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 13, 2021
CoLink Vallux Plating System510(k)Nov 18, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 18, 2021
CoLink Sfx Implant System510(k)May 4, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 4, 2021
CoLink Mfx Implant System510(k)Mar 12, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 12, 2021