FDA 510(k) Application Details - K201569

Device Classification Name Orthopedic Stereotaxic Instrument

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510(K) Number K201569
Device Name Orthopedic Stereotaxic Instrument
Applicant Curexo, Inc.
577, Gangnam-Daero, Seocho-Gu
Seoul 06530 KR
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Contact Jungeun Park
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Regulation Number 882.4560

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Classification Product Code OLO
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Date Received 06/11/2020
Decision Date 05/19/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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