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Device | ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | DJO, LLC 1430 DECISION STREET VISTA, CA 92081-8553 |
PMA Number | P910066 |
Supplement Number | S011 |
Date Received | 08/20/1998 |
Decision Date | 12/17/1999 |
Product Code |
LOF |
Docket Number | 00M-1073 |
Advisory Committee |
Orthopedic |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change to the indications for use and will be marked under the tradename SpinaLogic. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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