Device Classification Name |
Thoracolumbosacral Pedicle Screw System
|
510(k) Number |
K200070 |
Device Name |
ARx Spinal System |
Applicant |
Life Spine Inc. |
13951 S Quality Drive |
Huntley,
IL
60142
|
|
Applicant Contact |
Angela Batker |
Correspondent |
Life Spine Inc. |
13951 S Quality Drive |
Huntley,
IL
60142
|
|
Correspondent Contact |
Angela Batker |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/13/2020 |
Decision Date | 04/23/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|