Device Classification Name |
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
More FDA Info for this Device |
510(K) Number |
K173964 |
Device Name |
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
Applicant |
Arthrosurface, Inc.
28 Forge Parkway
Franklin, MA 02038 US
Other 510(k) Applications for this Company
|
Contact |
Dawn J. Wilson
Other 510(k) Applications for this Contact |
Regulation Number |
888.3690
More FDA Info for this Regulation Number |
Classification Product Code |
HSD
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
12/29/2017 |
Decision Date |
04/18/2018 |
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 |
|