Device Classification Name |
sacroiliac joint fixation
|
510(k) Number |
K201538 |
Device Name |
Life Spine SIMPACT Sacroiliac Joint Fixation 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 | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/09/2020 |
Decision Date | 09/18/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|