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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K252085
Device Name Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)
Applicant
Wright Medical Technology, Inc. (Stryker Corporation)
1023 Cherry Rd.
Memphis,  TN  38117
Applicant Contact Alayne Melancon
Correspondent
Wright Medical Technology, Inc. (Stryker Corporation)
1023 Cherry Rd.
Memphis,  TN  38117
Correspondent Contact Alayne Melancon
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
MBP  
Date Received07/02/2025
Decision Date 09/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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