Device Classification Name |
Thoracolumbosacral Pedicle Screw System
|
510(k) Number |
K120829 |
Device Name |
STAINLESS STEEL SPINAL SYSTEM |
Applicant |
THEKEN SPINE, LLC |
1153 Medina Rd. |
Medina,
OH
44256
|
|
Applicant Contact |
DALE DAVISON |
Correspondent |
THEKEN SPINE, LLC |
1153 Medina Rd. |
Medina,
OH
44256
|
|
Correspondent Contact |
DALE DAVISON |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/19/2012 |
Decision Date | 05/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|