Orthocon, Inc. FDA Approvals

0 new drug approvals and 22 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
Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)510(k)Sep 3, 2026	—	510(k)Substantially Equivalent (Special)	Sep 3, 2026
Permatage XT Settable Bone Putty510(k)Jun 15, 2026Neurology	Neurology	510(k)Substantially Equivalent (Special)	Jun 15, 2026
Permatage Flowable, Settable Hemostatic Bone Paste510(k)Jun 3, 2026	—	510(k)Substantially Equivalent (Traditional)	Jun 3, 2026
Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)510(k)Mar 16, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 16, 2026
Permatage Flowable, Settable Bone Paste510(k)Mar 13, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 13, 2026
MONTAGE XT Cranial Cement510(k)Jan 2, 2026Neurology	Neurology	510(k)Substantially Equivalent (Special)	Jan 2, 2026
MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty510(k)Dec 5, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Dec 5, 2024
Montage-XT Settable Bone Putty510(k)Nov 18, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Nov 18, 2024
Permatage Settable Bone Putty510(k)Sep 26, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Sep 26, 2024
Montage-XT Settable, Resorbable Bone Putty510(k)Aug 21, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 21, 2024
Montage Settable Bone Putty510(k)Jul 29, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jul 29, 2024
Montage Flowable Settable, Resorbable Bone Paste510(k)Feb 16, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 16, 2024
Montage- XT Settable, Resorbable Hemostatic Bone Putty510(k)Oct 12, 2023	—	510(k)Substantially Equivalent (Special)	Oct 12, 2023
MONTAGE-QS Settable, Resorbable Bone Putty510(k)Oct 12, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Oct 12, 2023
Montage Flowable Settable, Resorbable Bone Paste510(k)Sep 1, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 1, 2023
MONTAGE Settable, Resorbable Hemostatic Bone Putty510(k)Aug 30, 2023	—	510(k)Substantially Equivalent (Traditional)	Aug 30, 2023
Montage-QS Settable, Resorbable Bone Putty510(k)Aug 25, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 25, 2023
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste510(k)Jul 11, 2023	—	510(k)Substantially Equivalent (Traditional)	Jul 11, 2023
MONTAGE Settable, Resorbable Bone Putty510(k)Feb 3, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 3, 2023
MONTAGE Settable, Resorbable Bone Putty510(k)Jan 13, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 13, 2023
MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty510(k)Mar 11, 2022	—	510(k)Substantially Equivalent (Traditional)	Mar 11, 2022
HBP7 Settable Hemostatic Bone Putty510(k)Jan 19, 2021	—	510(k)Substantially Equivalent (Traditional)	Jan 19, 2021

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