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FDA 510(k) Application Details - K193472
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K193472
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
OrthoCircle Spine
15 East Montgomery Crossroads. Suite 3
Savannah, GA 31406 US
Other 510(k) Applications for this Company
Contact
Jack Mathews
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
12/16/2019
Decision Date
02/13/2020
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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