PMA P850007S033

Device
PHYSIO-STIM AND SPINAL-STIM
Applicant
Orthofix, Inc.
PMA number
P850007
Supplement
S033
Product code
LOF
Decision date
2014-08-27
Classification
Stimulator, Bone Growth, Non-invasive
Generic name
Stimulator, bone growth, non-invasive
Approval order statement
PROCESS CHANGE FOR THE BONE GROWTH STIMULATOR DEVICES.

Current openFDA PMA Record#

Device
PHYSIO-STIM AND SPINAL-STIM
Applicant
Orthofix, Inc.
PMA number
P850007
Supplement
S033
Product code
LOF
Generic name
Stimulator, bone growth, non-invasive
Decision date
2014-08-27
Decision code
OK30
Date received
2014-08-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
PROCESS CHANGE FOR THE BONE GROWTH STIMULATOR DEVICES.