The following data is part of a premarket notification filed by Lucero Medical, Llc with the FDA for Enduramesh, Model 762.xxx.
Device ID | K093207 |
510k Number | K093207 |
Device Name: | ENDURAMESH, MODEL 762.XXX |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | LUCERO MEDICAL, LLC PO BOX 67 Richfield, OH 44286 |
Contact | Jennifer Palinchik |
Correspondent | Jennifer Palinchik LUCERO MEDICAL, LLC PO BOX 67 Richfield, OH 44286 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-10-13 |
Decision Date | 2010-04-26 |
Summary: | summary |