Aegis Spine, Inc. FDA Approvals

0 new drug approvals and 5 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
ZESPIN SI Joint Fusion System510(k)Jan 20, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 20, 2023
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System510(k)Jan 11, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jan 11, 2023
ABTross ALIF Expandable Cage System510(k)Nov 3, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 3, 2022
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System510(k)Jun 30, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jun 30, 2022
XYPAN Expandable Lumbar Cage System510(k)Jan 29, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 29, 2021