Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K173967
Device Classification Name
Prosthesis, Hip, Hemi-, Femoral, Metal
More FDA Info for this Device
510(K) Number
K173967
Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Applicant
Osteoremedies LLC
6800 Poplar Avenue
Suite 120
Memphis, TN 38138 US
Other 510(k) Applications for this Company
Contact
Chris Hughes
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
12/29/2017
Decision Date
02/22/2018
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact