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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K092659
Device Name SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25
Applicant
Spinal USA
2050 Executive Dr..
Pear,  MS  39208
Applicant Contact JEFFREY JOHNSON
Correspondent
Spinal USA
2050 Executive Dr..
Pear,  MS  39208
Correspondent Contact JEFFREY JOHNSON
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/28/2009
Decision Date 11/17/2009
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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