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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K040199
Device Name OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS
Applicant
Osseus, LLC
3131 Princeton Pike, Bldg. 5
Suite 200
Lawrenceville,  NJ  08648
Applicant Contact SHAWN T HUXEL
Correspondent
Osseus, LLC
3131 Princeton Pike, Bldg. 5
Suite 200
Lawrenceville,  NJ  08648
Correspondent Contact SHAWN T HUXEL
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received01/29/2004
Decision Date 02/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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