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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K092110
Device Name WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)
Applicant
Sonoma Orthopedic Products, Inc.
650 Larkfield Center
Santa Rosa,  CA  95403
Applicant Contact CARLOS GONZALEZ
Correspondent
Sonoma Orthopedic Products, Inc.
650 Larkfield Center
Santa Rosa,  CA  95403
Correspondent Contact CARLOS GONZALEZ
Regulation Number888.3020
Classification Product Code
HSB  
Date Received07/14/2009
Decision Date 01/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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