The following data is part of a premarket notification filed by Lucero Medical, Llc with the FDA for Lucero Medical Cervical Cage System.
| Device ID | K200549 |
| 510k Number | K200549 |
| Device Name: | Lucero Medical Cervical Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Lucero Medical, LLC 6815 West Streetsboro Richfield, OH 44286 |
| Contact | Lee Strnad |
| Correspondent | Karen E. Warden BackRoads Consulting, Inc 12520 Heath Road Chesterland, OH 44026 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-03 |
| Decision Date | 2020-12-16 |