Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)— 510(k) K262769
Substantially EquivalentOrthocon, Inc.
FDA 510(k) clearance K262769 for Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT), Substantially Equivalent on 2026-09-03. Applicant: Orthocon, Inc.. Device class: Unclassified.
Summary
Orthocon's Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT) is filed under MTJ, bone wax. The settable, nonabsorbable, and hemostatic descriptions come from the device name.
The device class is listed as U, with no regulation number, and the classification panel is listed as Unknown. The Orthopedic review panel handled it as a Special 510(k).
Orthocon filed from Stamford, Connecticut. The decision came 30 calendar days after receipt (August 4 to September 3, 2026).
Clearance details
- Applicant
- Orthocon, Inc.
- Product code
- Product code MTJ
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Stamford, CT, US
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