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FDA 510(k) Application Details - K210792
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K210792
Device Name
Screw, Fixation, Bone
Applicant
Auxein Medical Private Limited
Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial
Area
Sonipat 131028 IN
Other 510(k) Applications for this Company
Contact
Rahul Luthra
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/15/2021
Decision Date
08/25/2021
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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