|Trade Name||SPINALOGIC BONE GROWTH STIMULATOR|
|Classification Name||stimulator, bone growth, non-invasive|
|Generic Name||spinalogic 1000 bone growth stimulator|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to *remove the following precaution from the summary of safety and effectiveness and professional labeling; "the safety and effectiveness of the spinalogic(r) has only been studied in patients having spinal fusion treatment. The safety and effectiveness of this device in patients receiving instrumentation, which may distort the magnetic field generated by the device and thus produce a less effective treatment, has not been established"; and *modify the following statement i nthe risks and benefits section of the patient labeling from: "the safety and benefit of the spinalogic(r) was not studied for patients who also have metal implants at the spot of their back surgery," to "the spinalogic(r) was not studied for patients who also have metal implants at the spot of their back surgery. ".