Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K905810 |
Device Name |
NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION |
Applicant |
JOINT MEDICAL PRODUCTS CORP. |
860 CANAL ST. |
STAMFORD,
CT
06902
|
|
Applicant Contact |
DEBRA L BING |
Correspondent |
JOINT MEDICAL PRODUCTS CORP. |
860 CANAL ST. |
STAMFORD,
CT
06902
|
|
Correspondent Contact |
DEBRA L BING |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 12/26/1990 |
Decision Date | 06/12/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|