FDA.report

510(k) K232998

Device
Montage- XT Settable, Resorbable Hemostatic Bone Putty
Applicant
Orthocon, Inc.
510(k) number
K232998
Product code
MTJ
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-12
Date received
2023-09-22
Classification name
Wax, Bone
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Howard Schrayer
Address
700 Fairfield Ave. - Suite 1 Stamford CT US 06902 06902

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MTJ

510(k)DeviceApplicantDecision date
K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.2023-08-30
K231386Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc.2023-07-11
K200452Meril-BonewaxM/s. Meril Endo Surgery Private Limited.2023-03-27
K220315MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.2022-03-11
K202363HBP7 Settable Hemostatic Bone PuttyOrthocon, Inc.2021-01-19
K193052HBP6 Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc.2020-03-27
K191140MONTAGE-QS Settable, Resorbable Hemostatic BoneOrthocon, Inc.2019-07-18
K153317HEMASORBPLUS Resorbable Hemostatic Bone PuttyOrthocon, Inc.2016-11-30
K153095ROP Resorbable Hemostasis MaterialResorbable Orthopedic Products, LLC2016-02-17
K152005MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.2015-10-15
K142348OsteoSeal Bone HemostatHemostasis, LLC2015-01-23
K143069HEMASORBPLUS press Resorable Hemostatic Bone PuttyOrthocon, Inc.2014-12-22
K141502HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTYOrthocon, Inc.2014-10-03
K142339HEMASORB Resorbable Hemostatic Bone PuttyOrthocon, LLC2014-09-26
K140117AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTYOrthocon, Inc.2014-02-11