FDA 510(k) Application Details - K213820

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K213820
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant Huvexel Co., Ltd
101-105 Megacenter, SKn Technopark, 124, Sagimakgol-ro
Jungwon-gu
Seongnam-si 13207 KR
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Contact Sung Kyu Hur
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 12/08/2021
Decision Date 03/25/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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