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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 K023564
Device Name OSSE-LIGN
Applicant
Osseus, LLC
34 Woodlane Rd.
Lawrenceville,  NJ  08648
Applicant Contact SHAWN T HUXEL
Correspondent
Osseus, LLC
34 Woodlane Rd.
Lawrenceville,  NJ  08648
Correspondent Contact SHAWN T HUXEL
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received10/23/2002
Decision Date 03/11/2003
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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