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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceBone Growth Stimulators
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantDjo, LLC
1430 Decision St.
Vista, CA 92081
PMA NumberP910066
Supplement NumberS030
Date Received07/03/2019
Decision Date08/02/2019
Reclassified Date05/18/2026
Product Code LOF 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Proposing a process change which introduces an upgraded version of the Automated Calibration System (ACS) for the SpinaLogic, OL1000 Dual Coil, and OL1000 Single Coil (SC) (sizes 1, 2, 3, 4) Bone Growth Stimulator devices.
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