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FDA 510(k) Application Details - K181048
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K181048
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
Neo Medical S.A.
Route de Lausanne 157 A
Villette 1096 CH
Other 510(k) Applications for this Company
Contact
Jonas Larsson
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
04/19/2018
Decision Date
01/29/2019
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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