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FDA 510(k) Application Details - K200224
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K200224
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
Indius Medical Technologies Pvt. Ltd.
Unit 12, Floors 1 and 2, Electronic Co-Operative Estate
Pune Satara Road
Pune 411009 IN
Other 510(k) Applications for this Company
Contact
Aditya Ingalhalikar
Other 510(k) Applications for this Contact
Regulation Number
888.3060
More FDA Info for this Regulation Number
Classification Product Code
KWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/29/2020
Decision Date
03/24/2020
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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