Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
More FDA Info for this Device |
510(K) Number |
K972361 |
Device Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
Applicant |
HOWMEDICA, INC.
359 VETERANS BLVD.
RUTHERFORD, NJ 07070-2584 US
Other 510(k) Applications for this Company
|
Contact |
FRANK MAAS
Other 510(k) Applications for this Contact |
Regulation Number |
888.3353
More FDA Info for this Regulation Number |
Classification Product Code |
LZO
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
06/25/1997 |
Decision Date |
09/23/1997 |
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 |
|