Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
|
510(k) Number |
K931676 |
Device Name |
S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG |
Applicant |
JOINT MEDICAL PRODUCTS CORP. |
860 CANAL ST. |
STAMFORD,
CT
06902
|
|
Applicant Contact |
KEVIN J CROSSEN |
Correspondent |
JOINT MEDICAL PRODUCTS CORP. |
860 CANAL ST. |
STAMFORD,
CT
06902
|
|
Correspondent Contact |
KEVIN J CROSSEN |
Regulation Number | 888.3320
|
Classification Product Code |
|
Date Received | 04/06/1993 |
Decision Date | 05/18/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|