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FDA 510(k) Application Details - K190227
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K190227
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
ChoiceSpine, LP
400 Erin Drive
Knoxville, TN 37919 US
Other 510(k) Applications for this Company
Contact
Kim Finch
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
02/05/2019
Decision Date
05/01/2019
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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