The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Montage-qs Settable, Resorbable Hemostatic Bone.
Device ID | K191140 |
510k Number | K191140 |
Device Name: | MONTAGE-QS Settable, Resorbable Hemostatic Bone |
Classification | Wax, Bone |
Applicant | Orthocon, Inc. 1 Bridge Street, Suite 121 Irvington, NY 10533 |
Contact | Howard L. Schrayer |
Correspondent | Howard L. Schrayer Orthocon, Inc. 1 Bridge Street, Suite 121 Irvington, NY 10533 |
Product Code | MTJ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-30 |
Decision Date | 2019-07-18 |