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FDA 510(k) Application Details - K223274
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K223274
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
Ulrich Medical USA
18221 Edison Avenue
Chesterfield, MO 63005 US
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Contact
Hans Stover
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Regulation Number
888.3070
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Classification Product Code
NKB
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More FDA Info for this Product Code
Date Received
10/24/2022
Decision Date
11/28/2022
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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