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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameMinimally Invasive Deformity Correction (MID-C) System
Classification Nameposterior ratcheting rod system
Generic Nameposterior ratcheting rod system
Applicant
Apifix , Ltd.
17 thelet st.
misgav business park 20174
HDE NumberH170001
Supplement NumberS016
Date Received10/09/2024
Decision Date12/12/2024
Product Code
QGP[ Registered Establishments with QGP ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for b&j medical located at 4268 east us hwy 6 kendallville, indiana, 46755 as an additional subcontractor manufacturer for apifix's mid-c extender components (extender rods and extender screw).
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