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FDA 510(k) Application Details - K210472
Device Classification Name
Orthopedic Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K210472
Device Name
Orthopedic Stereotaxic Instrument
Applicant
Spineart
3 chemin du prΘ 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
882.4560
More FDA Info for this Regulation Number
Classification Product Code
OLO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/17/2021
Decision Date
03/19/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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