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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 Interlaminal
510(k) Number K001105
Device Name MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS
Applicant
Depuyacromed
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact LISA GILMAN
Correspondent
Depuyacromed
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact LISA GILMAN
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received04/05/2000
Decision Date 04/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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