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FDA 510(k)

HBP7 Settable Hemostatic Bone Putty

K-Number: K202363 · 2021-01-19

ApplicantOrthocon, Inc.
Decision Date2021-01-19
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

HBP7 Settable Hemostatic Bone Putty is a medical device manufactured by Orthocon, Inc.. It received FDA 510(k) clearance on 2021-01-19 under approval number K202363. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HBP7 Settable Hemostatic Bone Putty?

HBP7 Settable Hemostatic Bone Putty is a medical device that received FDA 510(k) clearance on 2021-01-19. It is manufactured by Orthocon, Inc.. The 510(k) number is K202363.

When was HBP7 Settable Hemostatic Bone Putty approved by the FDA?

HBP7 Settable Hemostatic Bone Putty received FDA 510(k) clearance on 2021-01-19, under approval number K202363.

What company makes HBP7 Settable Hemostatic Bone Putty?

HBP7 Settable Hemostatic Bone Putty is manufactured by Orthocon, Inc..

What is the FDA product code for HBP7 Settable Hemostatic Bone Putty?

The FDA product code for HBP7 Settable Hemostatic Bone Putty is MTJ.

Other Devices by Orthocon, Inc.

K153317HEMASORBPLUS Resorbable Hemostatic Bone Putty K191140MONTAGE-QS Settable, Resorbable Hemostatic Bone K193052HBP6 Settable, Resorbable Hemostatic Bone Paste 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. K193052HBP6 Settable, Resorbable Hemostatic Bone PasteOrthocon, 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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