Device Classification Name |
spinal vertebral body replacement device - cervical
|
510(k) Number |
K191778 |
Device Name |
Omnia Medical VBR |
Applicant |
Omnia Medical, LLC |
6 Canyon Rd Suite 300 |
Morgantown,
WV
26508
|
|
Applicant Contact |
Troy Schifano |
Correspondent |
JALEX Medical |
30311 Clemens Rd Suite 5D |
Westlake,
OH
44145
|
|
Correspondent Contact |
Daniel Johnson |
Regulation Number | 888.3060
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/02/2019 |
Decision Date | 08/28/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|