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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wax, Bone
510(k) Number K262769
Device Name Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)
Applicant
Orthocon, Inc.
700 Fairfield Ave., Suite 1
Stamford,  CT  06902
Applicant Contact Alyssa McDermott
Correspondent
Orthocon, Inc.
700 Fairfield Ave., Suite 1
Stamford,  CT  06902
Correspondent Contact Alyssa McDermott
Classification Product Code
MTJ  
Date Received08/04/2026
Decision Date 09/03/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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