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FDA 510(k) Application Details - K210247
Device Classification Name
Device, Fixation, Proximal Femoral, Implant
More FDA Info for this Device
510(K) Number
K210247
Device Name
Device, Fixation, Proximal Femoral, Implant
Applicant
OsteoCentric Technologies d.b.a. OsteoCentric Trauma
75 West 300 North, Suite #150
Logan, UT 84321 US
Other 510(k) Applications for this Company
Contact
Todd Evans
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
JDO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/29/2021
Decision Date
04/30/2021
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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