Device Classification Name |
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
More FDA Info for this Device |
510(K) Number |
K193122 |
Device Name |
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
Applicant |
Biocore9, LLC.
9 Whippany Road, Bldg A1, Unit 12
Whippany, NJ 07981 US
Other 510(k) Applications for this Company
|
Contact |
Stan Matlak
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 |
11/12/2019 |
Decision Date |
05/15/2020 |
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 |
|