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FDA 510(k) Application Details - K190071
Device Classification Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
More FDA Info for this Device
510(K) Number
K190071
Device Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant
SPINEART
3 Chemin du pre Fleuri
Plan Les Ouates 1228 CH
Other 510(k) Applications for this Company
Contact
Franck Pennesi
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
NKG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/15/2019
Decision Date
02/25/2019
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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