Device Classification Name |
intervertebral fusion device with integrated fixation, lumbar
|
510(k) Number |
K202230 |
Device Name |
NEXXT MATRIXX Stand Alone ALIF System |
Applicant |
Nexxt Spine LLC |
14425 Bergen Blvd, Suite B |
Noblesville,
IN
46060
|
|
Applicant Contact |
Andy Elsbury |
Correspondent |
BackRoads Consulting |
PO BOX 566 |
Chesterland,
OH
44026
|
|
Correspondent Contact |
Karen E Warden |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 08/07/2020 |
Decision Date | 12/15/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|