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FDA 510(k) Application Details - K213653
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K213653
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
Solco Biomedical Company India Private Limited
5 & 6 Third FloorB. Jadav Chambers, Above Sales India
Ahmedabad 380009 IN
Other 510(k) Applications for this Company
Contact
Darshak Shah
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
MAX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/19/2021
Decision Date
12/19/2022
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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