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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K071877
Device Name LANX SPINAL FIXATION SYSTEM
Applicant
Lanx, LLC
1835 Market St., 28th Floor
Philadelphia,  PA  19102
Applicant Contact JANICE M HOGAN
Correspondent
Lanx, LLC
1835 Market St., 28th Floor
Philadelphia,  PA  19102
Correspondent Contact JANICE M HOGAN
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received07/09/2007
Decision Date 09/17/2007
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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