In2bones Sas FDA Approvals

0 new drug approvals and 3 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
QUANTUM® Patient Specific Instrumentation (PSI) System510(k)Apr 23, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 23, 2024
QUANTUM Patient Specific Instrumentation (PSI) System510(k)Apr 6, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 6, 2023
QUANTUM® Patient Specific Instrumentation (PSI) System510(k)Aug 11, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 11, 2021