| 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 | OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS |
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| Generic Name | Stimulator, bone growth, non-invasive |
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| Regulation Number | 890.5870 |
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| Applicant | Djo, LLC
1430 Decision St.
Vista, CA 92081 |
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| PMA Number | P910066 |
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| Supplement Number | S019 |
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| Date Received | 01/20/2004 |
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| Decision Date | 09/10/2004 |
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| Reclassified Date | 05/18/2026 |
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| Product Code |
LOF |
| Advisory Committee |
Orthopedic |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
APPROVAL FOR 1) CHANGE IN THE LABELING TO REFLECT THE NEW COMPANY OWNERSHIP FROM ORTHOLOGIC TO DJ ORTHOPEDICS/ REGENTEK; 2) ADDITION OF A PRODUCT SPECIFICATIONS SECTION TO ALL MANUALS TO COMPLY WITH CANADIAN STANDARDS ASSOCIATION. (APPLIES TO OL SERIES AND SPINALOGIC MANUALS); 3) ADDITION OF REFERENCE SECTION (APPLIES TO SPINALOGIC MANUALS ONLY); AND 4) IN RISK AND BENEFITS SECTION OF THE SPINALOGIC PATIENT MANUAL, REVISION THE STATEMENT "20% GREATER CHANCE OF BACK SURGERY HEALING" TO "THE BENEFIT OF THE SPINALOGIC IS THAT YOU HAVE A GREATER CHANCE OF YOUR BACK SURGERY HEALING IF YOU USE THE DEVICE EVERY DAY THAN IF YOU DON NOT USE IT." |
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