The following data is part of a premarket notification filed by Infront Medical, Llc with the FDA for Infront Lumbar Interbody Fusion System.
| Device ID | K141443 |
| 510k Number | K141443 |
| Device Name: | INFRONT LUMBAR INTERBODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | INFRONT MEDICAL, LLC 1033 US HIGHWAY 46 EAST, SUITE A202 Clifton, NJ 07013 |
| Contact | John Kuczynski |
| Correspondent | John Kuczynski INFRONT MEDICAL, LLC 1033 US HIGHWAY 46 EAST, SUITE A202 Clifton, NJ 07013 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-02 |
| Decision Date | 2014-08-28 |
| Summary: | summary |