The following data is part of a premarket notification filed by Advanced Research Medical, Llc with the FDA for Lumbar Interbody Fusion System (ollif).
| Device ID | K173947 |
| 510k Number | K173947 |
| Device Name: | Lumbar Interbody Fusion System (OLLIF) |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Advanced Research Medical, LLC 1519 Highway 13 East Burnsville, MN 55337 |
| Contact | John D Siegel |
| Correspondent | James A. Dunning QPC Services, LLC 537 N. Spencer Mesa, AZ 85203 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-27 |
| Decision Date | 2018-07-25 |
| Summary: | summary |