The following data is part of a premarket notification filed by Lucero Medical, Llc with the FDA for Enduramesh.
| Device ID | K122622 |
| 510k Number | K122622 |
| Device Name: | ENDURAMESH |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | LUCERO MEDICAL, LLC 33490 PIN OAK PARKWAY Avon Lake, OH 44012 |
| Contact | Jennifer Palinchik |
| Correspondent | Jennifer Palinchik LUCERO MEDICAL, LLC 33490 PIN OAK PARKWAY Avon Lake, OH 44012 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-28 |
| Decision Date | 2012-09-19 |
| Summary: | summary |