Device Classification Name |
prosthesis, hip, semi-constrained (metal cemented acetabular component)
|
510(k) Number |
K934440 |
Device Name |
PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES |
Applicant |
HOWMEDICA CORP. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Applicant Contact |
MARGARET F CROWE |
Correspondent |
HOWMEDICA CORP. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Correspondent Contact |
MARGARET F CROWE |
Regulation Number | 888.3320
|
Classification Product Code |
|
Date Received | 07/06/1993 |
Decision Date | 02/22/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|