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510(k) K142339

Device
HEMASORB Resorbable Hemostatic Bone Putty
Applicant
ORTHOCON, LLC
510(k) number
K142339
Product code
MTJ  
Decision
Substantially Equivalent (SESE)
Decision date
2014-09-26
Date received
2014-08-21
Regulation
510(k) Premarket Notification
Classification name
Wax, Bone
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
U
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Howard L Schrayer
Address
1 Bridge St. - Suite 121 Irvington NY US 10533 10533

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MTJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.2023-10-12
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
K140117AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTYOrthocon, Inc.2014-02-11

Legacy Summary#

summary

FDA Review#

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