Device Classification Name |
Arthroscope
|
510(k) Number |
K121482 |
Device Name |
INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY |
Applicant |
THEKEN SPINE LLC |
1153 MEDINA RD. |
MEDINA,
OH
44256 -0000
|
|
Applicant Contact |
DALE DAVISON |
Correspondent |
THEKEN SPINE LLC |
1153 MEDINA RD. |
MEDINA,
OH
44256 -0000
|
|
Correspondent Contact |
DALE DAVISON |
Regulation Number | 888.1100
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/18/2012 |
Decision Date | 08/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|