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FDA 510(k) Application Details - K220810
Device Classification Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
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510(K) Number
K220810
Device Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant
Medicrea International
5389 Route de Strasbourg - Vancia
Rillieux-La-Pape 69140 FR
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Contact
Karine Trogneux
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Regulation Number
000.0000
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Classification Product Code
NKG
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More FDA Info for this Product Code
Date Received
03/21/2022
Decision Date
04/19/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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