Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
More FDA Info for this Device |
510(K) Number |
K961304 |
Device Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
Applicant |
EXACTECH, INC.
4613 N.W. 6TH STREET, SUITE D
GAINESVILLE, FL 32609 US
Other 510(k) Applications for this Company
|
Contact |
MARTHA C MILLER
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 |
04/04/1996 |
Decision Date |
10/01/1996 |
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 |
|