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FDA 510(k)

HBP6 Settable, Resorbable Hemostatic Bone Paste

K-Number: K193052 · 2020-03-27

ApplicantOrthocon, Inc.
Decision Date2020-03-27
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

HBP6 Settable, Resorbable Hemostatic Bone Paste is a medical device manufactured by Orthocon, Inc.. It received FDA 510(k) clearance on 2020-03-27 under approval number K193052. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HBP6 Settable, Resorbable Hemostatic Bone Paste?

HBP6 Settable, Resorbable Hemostatic Bone Paste is a medical device that received FDA 510(k) clearance on 2020-03-27. It is manufactured by Orthocon, Inc.. The 510(k) number is K193052.

When was HBP6 Settable, Resorbable Hemostatic Bone Paste approved by the FDA?

HBP6 Settable, Resorbable Hemostatic Bone Paste received FDA 510(k) clearance on 2020-03-27, under approval number K193052.

What company makes HBP6 Settable, Resorbable Hemostatic Bone Paste?

HBP6 Settable, Resorbable Hemostatic Bone Paste is manufactured by Orthocon, Inc..

What is the FDA product code for HBP6 Settable, Resorbable Hemostatic Bone Paste?

The FDA product code for HBP6 Settable, Resorbable Hemostatic Bone Paste is MTJ.

Other Devices by Orthocon, Inc.

K153317HEMASORBPLUS Resorbable Hemostatic Bone Putty K191140MONTAGE-QS Settable, Resorbable Hemostatic Bone K202363HBP7 Settable Hemostatic Bone Putty K220315MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty K231475MONTAGE-QS Settable, Resorbable Bone Putty K232998Montage- XT Settable, Resorbable Hemostatic Bone Putty

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Related Devices (Code: MTJ)

K153317HEMASORBPLUS Resorbable Hemostatic Bone PuttyOrthocon, Inc. K153095ROP Resorbable Hemostasis MaterialResorbable Orthopedic Products, LLC K191140MONTAGE-QS Settable, Resorbable Hemostatic BoneOrthocon, Inc. K202363HBP7 Settable Hemostatic Bone PuttyOrthocon, Inc. K220315MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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