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主內容區域
“EZ MIS” Pedicle Screw Spinal System
US FDA 510(k): K251251 — substantially equivalent (cleared for US marketing). The CHANPIN Pedicle Screw Spinal System has been found substantially equivalent to a legally marketed predicate device and may be marketed in the United States. │
TFDA (Taiwan): License No. 007371 (approved)