Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K173947 |
Device Name |
Lumbar Interbody Fusion System (OLLIF) |
Applicant |
Advanced Research Medical, LLC |
1519 Highway 13 East |
Burnsville,
MN
55337
|
|
Applicant Contact |
John D Siegel |
Correspondent |
QPC Services, LLC |
537 N. Spencer |
Mesa,
AZ
85203
|
|
Correspondent Contact |
James A. Dunning |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 12/27/2017 |
Decision Date | 07/25/2018 |
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
|
|
|