Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
More FDA Info for this Device |
510(K) Number |
K991987 |
Device Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
Applicant |
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW, IN 46581-0587 US
Other 510(k) Applications for this Company
|
Contact |
DALENE HUFZIGER BINKLEY
Other 510(k) Applications for this Contact |
Regulation Number |
888.3350
More FDA Info for this Regulation Number |
Classification Product Code |
JDI
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
06/14/1999 |
Decision Date |
06/28/1999 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|