510(k) K262769
K262769 is an FDA 510(k) premarket notification submitted by Orthocon, Inc. for the device "Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)". The FDA issued a decision of Substantially Equivalent on September 3, 2026. The device falls under product code MTJ (Wax, Bone), a Class U device. Orthocon, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 2026
- Date Received
- August 4, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wax, Bone
- Device Class
- Class U
- Regulation Number
- Review Panel
- OR
- Submission Type