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FDA 510(k) Application Details - K203607
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K203607
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
Biedermann Motech GmbH & Co. KG
Bertha-von Suttner-Strasse 23
Villingen-Schwenningen 78054 DE
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Contact
Gerd Federle
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
NKB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/10/2020
Decision Date
08/20/2021
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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