Permatage Flowable, Settable Bone Paste— 510(k) K253732
Substantially EquivalentOrthocon, Inc.
FDA 510(k) clearance K253732 for Permatage Flowable, Settable Bone Paste, Substantially Equivalent on 2026-03-13. Applicant: Orthocon, Inc.. Device class: 2.
Summary
Orthocon's Permatage Flowable, Settable Bone Paste is filed under GXP, methyl methacrylate for cranioplasty. The record doesn't describe the product beyond its name and that code name.
Class II, 21 CFR 882.5300. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Orthocon filed from Stamford, Connecticut. Review took 109 calendar days (November 24, 2025 to March 13, 2026).
Clearance details
- Applicant
- Orthocon, Inc.
- Product code
- Product code GXP
- Device class
- Class 2
- Regulation
- 21 CFR 882.5300
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, US
Recent devices under product code GXP
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- K253447 — Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
- K243526 — MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
- K243506 — Montage-XT Settable Bone Putty
Data sourced from openFDA. This site is unofficial and independent of the FDA.