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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Cement Restrictor
510(k) Number K033953
Device Name OPTIMESH 500E CEMENT RESTRICTOR
Applicant
SPINEOLOGY, INC.
1815 NORTHWESTERN AVE.
STILLWATER,  MN  55082
Applicant Contact PAMELA SNYDER
Correspondent
SPINEOLOGY, INC.
1815 NORTHWESTERN AVE.
STILLWATER,  MN  55082
Correspondent Contact PAMELA SNYDER
Regulation Number878.3300
Classification Product Code
JDK  
Date Received12/22/2003
Decision Date 07/06/2004
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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