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FDA 510(k) Application Details - K213118
Device Classification Name
More FDA Info for this Device
510(K) Number
K213118
Device Name
Dakota ALIF System
Applicant
Precision Spine, Inc.
2050 Executive Drive.
Pear, MS 39208 US
Other 510(k) Applications for this Company
Contact
Michael Dawson
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/27/2021
Decision Date
04/01/2022
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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