Device Classification Name |
Prosthesis, Hip, Hemi-, Femoral, Metal
More FDA Info for this Device |
510(K) Number |
K172906 |
Device Name |
Prosthesis, Hip, Hemi-, Femoral, Metal |
Applicant |
OsteoRemedies, LLC
6800 Poplar Avenue, #120
Germantown, TN 38138 US
Other 510(k) Applications for this Company
|
Contact |
Eric Stookey
Other 510(k) Applications for this Contact |
Regulation Number |
888.3360
More FDA Info for this Regulation Number |
Classification Product Code |
KWL
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
09/22/2017 |
Decision Date |
08/29/2018 |
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 |
|