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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K051216
Device Name HYDRALOK SYSTEM
Applicant
ALTIVA CORP.
9800-I SOUTHERN PINE BLVD.
CHARLOTTE,  NC  28273
Applicant Contact JOHN KAPITAN
Correspondent
ALTIVA CORP.
9800-I SOUTHERN PINE BLVD.
CHARLOTTE,  NC  28273
Correspondent Contact JOHN KAPITAN
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received05/12/2005
Decision Date 07/19/2005
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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