Ph.D. PaxMed International LLC / Titan Spine LLC / Surgicraft Ltd. / Z 510(k) Summary OsteoVasive LLC / OsteoVasive LLC / RSB Spine LLC / K133827 Trade / SpineSmith Partners LP / DEVICE NAME AND CLASSIFICATION Trade / 1 PSC Publishing / ADMINISTRATIVE INFORMATION Manufacturer Name OsteoVasive LLC / /
Country
United States / / /
Event
FDA Phase / /
Facility
New Hampshire Avenue Document Control Center / / /
IndustryTerm
subject device / treatment of degenerative disc disease / stand alone device / announcements concerning your device / predicate devices / body fusion device / predicate device / spinal device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address http /
MedicalCondition
degenerative disc disease / back pain / I spondylolisthesis / /
Organization
Orthopedic Devices Office / Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / Device Evaluation Center for Devices / Department of Health and Human Services Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Devices and Radiological Health Enclosure DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved / Mark N. Melkerson Director Division / CDRH’s office of Surveillance / /
Person
Lori A. Wiggins / Silver Spring / Kevin A. Thomas / Mark N. Melkerson / / /
Position
President / physician / Representative /Consultant / /
Microsoft Word - K133827 510k summary revised[removed]docx