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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K922788
Device Name BIOACTION LOW PROFILE SCREW SYSTEM
Applicant
Orthopaedic Biosystems
7725 E. Redfield Rd.
Unit 102
Scottsdale,  AZ  85260
Applicant Contact CHIP KABRUD
Correspondent
Orthopaedic Biosystems
7725 E. Redfield Rd.
Unit 102
Scottsdale,  AZ  85260
Correspondent Contact CHIP KABRUD
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/09/1992
Decision Date 03/12/1993
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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