Medical Device Manufacturer · US , Stamford , CT

Orthocon, Inc. - FDA 510(k) Cleared Devices

36 submissions · 36 cleared · Since 2006

Recent clearances: Permatage XT Settable Bone Putty, Permatage Flowable, Settable Hemostatic Bone Paste, Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)

Official Website

36

Total

36

Cleared

0

Denied

FDA 510(k) Regulatory Record - Orthocon, Inc. Neurology ✕

8 devices

1-8 of 8

Cleared Jun 15, 2026

Permatage XT Settable Bone Putty

Neurology · 60d

Cleared Mar 16, 2026

Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)

Neurology · 165d

Cleared Mar 13, 2026

Permatage Flowable, Settable Bone Paste

Neurology · 109d

Cleared Jan 02, 2026

MONTAGE XT Cranial Cement

Neurology · 30d

Cleared Sep 26, 2024

Permatage Settable Bone Putty

Neurology · 164d

Cleared Feb 16, 2024

Montage Flowable Settable, Resorbable Bone Paste

Neurology · 158d

Cleared Oct 12, 2023

MONTAGE-QS Settable, Resorbable Bone Putty

Neurology · 143d

Cleared Jan 13, 2023

MONTAGE Settable, Resorbable Bone Putty

Neurology · 196d