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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 K242299
Device Name NovaBone Putty - Synthetic Bioactive Bone Graft
Applicant
Novabone Products, LLC
13510 NW Us Highway 441
Alachua,  FL  32615
Applicant Contact Ed Horton
Correspondent
Bruder Consulting & Venture Group
268 Glen Place
Franklin,  NJ  07417
Correspondent Contact Scott Bruder
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/02/2024
Decision Date 09/25/2024
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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