Device Classification Name |
prosthesis, hip, semi-constrained (metal cemented acetabular component)
|
510(k) Number |
K870234 |
Device Name |
P.T.H. METAL-BACKED ACETABULAR CUP |
Applicant |
ORTHOPAEDIC DEVICE CORP. |
6 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Applicant Contact |
ALEX KHOWAYLO |
Correspondent |
ORTHOPAEDIC DEVICE CORP. |
6 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Correspondent Contact |
ALEX KHOWAYLO |
Regulation Number | 888.3320
|
Classification Product Code |
|
Date Received | 01/21/1987 |
Decision Date | 03/20/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|