Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ORTHOLOGIC 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 | S004 |
Date Received | 04/05/1996 |
Decision Date | 06/25/1997 |
Product Code |
LOF |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ORTHOLOGIC 1000 SINGLE CLOSED COIL SOFT PACK BONE GROWTH STIMULATOR IN SIZES XS, S, M, L, AND XL AND FOR THE ORTHOLOGIC 1000 BONE GROWTH STIMULATOR IN THE MEDIUM SIZE. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES OL 1000-CC AND OL 1000 (MEDIUM) AND ARE INDICATED FOR THE NONINVASIVE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VETEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECT IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED. |
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