Device Classification Name |
arthroscope
|
510(k) Number |
K002931 |
Device Name |
METRX SYSTEM |
Applicant |
MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Applicant Contact |
RICHARD W TREHARNE |
Correspondent |
MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Correspondent Contact |
RICHARD W TREHARNE |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 09/20/2000 |
Decision Date | 11/24/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|