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FDA 510(k)

MONTAGE-QS Settable, Resorbable Bone Putty

K-Number: K231475 · 2023-10-12

ApplicantOrthocon, Inc.
Decision Date2023-10-12
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MONTAGE-QS Settable, Resorbable Bone Putty is a medical device manufactured by Orthocon, Inc.. It received FDA 510(k) clearance on 2023-10-12 under approval number K231475. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONTAGE-QS Settable, Resorbable Bone Putty?

MONTAGE-QS Settable, Resorbable Bone Putty is a medical device that received FDA 510(k) clearance on 2023-10-12. It is manufactured by Orthocon, Inc.. The 510(k) number is K231475.

When was MONTAGE-QS Settable, Resorbable Bone Putty approved by the FDA?

MONTAGE-QS Settable, Resorbable Bone Putty received FDA 510(k) clearance on 2023-10-12, under approval number K231475.

What company makes MONTAGE-QS Settable, Resorbable Bone Putty?

MONTAGE-QS Settable, Resorbable Bone Putty is manufactured by Orthocon, Inc..

What is the FDA product code for MONTAGE-QS Settable, Resorbable Bone Putty?

The FDA product code for MONTAGE-QS Settable, Resorbable Bone Putty is GXP.

Other Devices by Orthocon, Inc.

K153317HEMASORBPLUS Resorbable Hemostatic Bone Putty K191140MONTAGE-QS Settable, Resorbable Hemostatic Bone K193052HBP6 Settable, Resorbable Hemostatic Bone Paste K202363HBP7 Settable Hemostatic Bone Putty K220315MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty K232998Montage- XT Settable, Resorbable Hemostatic Bone Putty

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Related Devices (Code: GXP)

K162864OsteoVation ImpactSkeletal Kinetics, LLC K182742DB-CMFDimensional Bioceramics, LLC K221933MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc. K241027Permatage Settable Bone PuttyOrthocon, Inc. K232771Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc. K253732Permatage Flowable, Settable Bone PasteOrthocon, 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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