Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K944321 |
Device Name |
S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II |
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 | 888.3560
|
Classification Product Code |
|
Date Received | 09/02/1994 |
Decision Date | 08/14/1995 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|