Premarket Approval (PMA)

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.

• Device: OL1000/OL1000 SC and SpinaLogic Bone Growth Stimulators
• Generic Name: Stimulator, bone growth, non-invasive
• Regulation Number: 890.5870
• Applicant: Djo, LLC; 1430 Decision St.; Vista, CA 92081
• PMA Number: P910066
• Supplement Number: S029
• Date Received: 05/23/2018
• Decision Date: 06/19/2018
• Reclassified Date: 05/18/2026
• Product Code: LOF
• Advisory Committee: Orthopedic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Change in supplier of the sensor board.