K2m, Inc. FDA Approvals

0 new drug approvals and 4 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
Q Pedicle Instruments510(k)Mar 17, 2026Neurology	Neurology	510(k)Substantially Equivalent (Special)	Mar 17, 2026
Vulcan Spinal System510(k)Feb 10, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 10, 2026
Q Interbody Instruments510(k)Feb 6, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 6, 2026
CAPRI Corpectomy Cage System510(k)Feb 24, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 24, 2022