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FDA 510(k)

Permatage Settable Bone Putty

K-Number: K241027 · 2024-09-26

ApplicantOrthocon, Inc.
Decision Date2024-09-26
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Permatage Settable Bone Putty is a medical device manufactured by Orthocon, Inc.. It received FDA 510(k) clearance on 2024-09-26 under approval number K241027. 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 Permatage Settable Bone Putty?

Permatage Settable Bone Putty is a medical device that received FDA 510(k) clearance on 2024-09-26. It is manufactured by Orthocon, Inc.. The 510(k) number is K241027.

When was Permatage Settable Bone Putty approved by the FDA?

Permatage Settable Bone Putty received FDA 510(k) clearance on 2024-09-26, under approval number K241027.

What company makes Permatage Settable Bone Putty?

Permatage Settable Bone Putty is manufactured by Orthocon, Inc..

What is the FDA product code for Permatage Settable Bone Putty?

The FDA product code for Permatage Settable Bone Putty is GXP.

Other Devices by Orthocon, Inc.

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Related Devices (Code: GXP)

K162864OsteoVation ImpactSkeletal Kinetics, LLC K182742DB-CMFDimensional Bioceramics, LLC K231475MONTAGE-QS Settable, Resorbable Bone PuttyOrthocon, Inc. K221933MONTAGE Settable, Resorbable 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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