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FDA 510(k) Application Details - K181203
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K181203
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
Spineart
3 Chemin du PrΘ Fleuri
Plan Les Ouates 1228 CH
Other 510(k) Applications for this Company
Contact
Frank Pennesi
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
05/07/2018
Decision Date
06/28/2018
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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