Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Permatage Flowable, Settable Bone Paste

K-Number: K253732 · 2026-03-13

ApplicantOrthocon, Inc.
Decision Date2026-03-13
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Permatage Flowable, Settable Bone Paste is a medical device manufactured by Orthocon, Inc.. It received FDA 510(k) clearance on 2026-03-13 under approval number K253732. 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 Flowable, Settable Bone Paste?

Permatage Flowable, Settable Bone Paste is a medical device that received FDA 510(k) clearance on 2026-03-13. It is manufactured by Orthocon, Inc.. The 510(k) number is K253732.

When was Permatage Flowable, Settable Bone Paste approved by the FDA?

Permatage Flowable, Settable Bone Paste received FDA 510(k) clearance on 2026-03-13, under approval number K253732.

What company makes Permatage Flowable, Settable Bone Paste?

Permatage Flowable, Settable Bone Paste is manufactured by Orthocon, Inc..

What is the FDA product code for Permatage Flowable, Settable Bone Paste?

The FDA product code for Permatage Flowable, Settable Bone Paste 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

View all 22 devices →

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. K241027Permatage Settable Bone PuttyOrthocon, Inc. K232771Montage Flowable Settable, Resorbable 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.

↑