Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K182920 |
Device Name |
MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF) |
Applicant |
MiRus, LLC |
2150 Newmarket Parkway |
Marietta,
GA
30067
|
|
Applicant Contact |
Jordan Bauman |
Correspondent |
MiRus, LLC |
2150 Newmarket Parkway SE, Suite 108 |
Marietta,
GA
30067
|
|
Correspondent Contact |
Jordan Bauman |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 10/19/2018 |
Decision Date | 03/13/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|