Device Classification Name |
Orthosis, Spondylolisthesis Spinal Fixation
|
510(k) Number |
K991528 |
Device Name |
MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR |
Applicant |
DANEK MEDICAL, INC. |
1800 PYRAMID PL. |
MEMPHIS,
TN
38132
|
|
Applicant Contact |
RICHARD W TREHARNE |
Correspondent |
DANEK MEDICAL, INC. |
1800 PYRAMID PL. |
MEMPHIS,
TN
38132
|
|
Correspondent Contact |
RICHARD W TREHARNE |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/03/1999 |
Decision Date | 05/28/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|