Device Classification Name |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
More FDA Info for this Device |
510(K) Number |
K974434 |
Device Name |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
Applicant |
OSTEONICS CORP.
59 ROUTE 17
ALLENDALE, NJ 07401-1677 US
Other 510(k) Applications for this Company
|
Contact |
TERRY S HERIDAN
Other 510(k) Applications for this Contact |
Regulation Number |
888.3530
More FDA Info for this Regulation Number |
Classification Product Code |
HRY
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
11/24/1997 |
Decision Date |
01/12/1998 |
Decision |
SN - Substantially Equivalent for Some Indications |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
|
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|