Permatage XT Settable Bone Putty— 510(k) K261265
Substantially EquivalentOrthocon, Inc.
FDA 510(k) clearance K261265 for Permatage XT Settable Bone Putty, Substantially Equivalent on 2026-06-15. Applicant: Orthocon, Inc.. Device class: 2.
Summary
Orthocon's Permatage XT Settable Bone Putty is filed under GXP, methyl methacrylate for cranioplasty. The settable description comes from the device name; the record doesn't give the putty's composition.
Class II, 21 CFR 882.5300. Neurology is both the classification panel and the review panel, and it came in as a Special 510(k).
Orthocon filed from Stamford, Connecticut. The decision came 60 calendar days after FDA received it (April 16 to June 15, 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
- Special
- Location
- Stamford, CT, US
Recent devices under product code GXP
view allMore clearances from Orthocon, Inc.
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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.