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FDA 510(k)

MONTAGE Settable, Resorbable Bone Putty

K-Number: K221933 · 2023-01-13

ApplicantOrthocon, Inc.
Decision Date2023-01-13
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MONTAGE Settable, Resorbable Bone Putty is a medical device manufactured by Orthocon, Inc.. It received FDA 510(k) clearance on 2023-01-13 under approval number K221933. 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 Settable, Resorbable Bone Putty?

MONTAGE Settable, Resorbable Bone Putty is a medical device that received FDA 510(k) clearance on 2023-01-13. It is manufactured by Orthocon, Inc.. The 510(k) number is K221933.

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

MONTAGE Settable, Resorbable Bone Putty received FDA 510(k) clearance on 2023-01-13, under approval number K221933.

What company makes MONTAGE Settable, Resorbable Bone Putty?

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

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

The FDA product code for MONTAGE 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 K231475MONTAGE-QS Settable, Resorbable Bone Putty

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Related Devices (Code: GXP)

K162864OsteoVation ImpactSkeletal Kinetics, LLC K182742DB-CMFDimensional Bioceramics, LLC K231475MONTAGE-QS 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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