Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K183659 |
Device Name |
Omnia Medical Rotary PLIF System |
Applicant |
Omnia Medical, LLC |
6 Canyon Rd Suite 300 |
Morgantown,
WV
26508
|
|
Applicant Contact |
Troy Schifano |
Correspondent |
JALEX Medical |
30311 Clemens Road |
Suite 5D |
Westlake,
OH
44145
|
|
Correspondent Contact |
Daniel Johnson |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 12/27/2018 |
Decision Date | 02/06/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|