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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K020279
Device Name FOREX CORPORATION, OPTIMA, SPINAL SYSTEM
Applicant
Forex Corp.
6132 S. 380 W., Suite 200
Murray,  UT  84107 -6988
Applicant Contact ROBERT MALONE
Correspondent
Forex Corp.
6132 S. 380 W., Suite 200
Murray,  UT  84107 -6988
Correspondent Contact ROBERT MALONE
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWQ   MNH  
Date Received01/28/2002
Decision Date 06/20/2002
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
Recalls CDRH Recalls
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