Synthes Hemostatic Bone Putty

FDA 510(k) K113079 · Synthes (Usa) Products, LLC/Norian Corporation

Substantially Equivalent

510(k) numberK113079

Submission

Device name
Synthes Hemostatic Bone Putty
Applicant
Synthes (Usa) Products, LLC/Norian Corporation
West Chester, PA, US
Received
October 17, 2011
Decision date
December 13, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MTJ – Wax, Bone
Device class
Unclassified
Implant
Yes

Other 510(k)s with product code MTJ

510(k)DeviceApplicantDecision
K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)MTJ · Special Orthocon, Inc.09/03/2026SE
K261439Permatage Flowable, Settable Hemostatic Bone PasteMTJ · Traditional Orthocon, Inc.06/03/2026SE
K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyMTJ · Special Orthocon, Inc.10/12/2023SE
K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyMTJ · Traditional Orthocon, Inc.08/30/2023SE
K231386Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteMTJ · Traditional Orthocon, Inc.07/11/2023SE
K200452Meril-BonewaxMTJ · Traditional M/s. Meril Endo Surgery Private Limited.03/27/2023SE
K220315MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyMTJ · Traditional Orthocon, Inc.03/11/2022SE
K202363HBP7 Settable Hemostatic Bone PuttyMTJ · Traditional Orthocon, Inc.01/19/2021SE
K193052HBP6 Settable, Resorbable Hemostatic Bone PasteMTJ · Traditional Orthocon, Inc.03/27/2020SE
K191140MONTAGE-QS Settable, Resorbable Hemostatic BoneMTJ · Traditional Orthocon, Inc.07/18/2019SE

Questions and answers

When was Synthes Hemostatic Bone Putty cleared by the FDA?

Synthes Hemostatic Bone Putty (K113079) received a 510(k) decision of Substantially Equivalent on December 13, 2011, 57 days after the submission was received.

What is the product code of K113079?

The FDA product code is MTJ – Wax, Bone, a Unclassified device.