Device Classification Name |
Intervertebral Fusion Device With Integrated Fixation, Lumbar
|
510(k) Number |
K211769 |
Device Name |
OneLIF Intervertebral Body Replacement System |
Applicant |
NovApproach Spine |
13900 Tech City Circle, Suite 300 |
Alachua,
FL
32615
|
|
Applicant Contact |
Ronald P. Green |
Correspondent |
Empirical Testing Corp. |
4628 Northpark Drive |
Colorado Springs,
CO
80918
|
|
Correspondent Contact |
Meredith Lee May |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/08/2021 |
Decision Date | 09/07/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|