Lucero Medical, LLC
United StatesFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Lucero Medical, LLC makes
Lucero Medical, LLC manufactures spinal fixation devices, including the ENDURAMESH (Model 762.XXX) and ENDURAMESH, which are designed for internal spinal stabilization, as well as the Lucero Medical Cervical Cage System for cervical spine support.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) clearance pathway. The company is based in the United States.
Catalogue
Enduramesh, Model 762.XXX Ref K093207
Regimes: 510(k) Registry: 510(k)Enduramesh Ref K122622
Regimes: 510(k) Registry: 510(k)Lucero Medical Cervical Cage System Ref K200549
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Lucero Medical, LLC, the earliest on 2012-01-11 and the most recent on 2012-07-15. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use and sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 15 Jul 2012 Z-2368-2012 Class II Terminated The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.
- 11 Jan 2012 Z-1059-2012 Not yet classified Terminated During an FDA inspection the firm was informed that the device marketed is not the device cleared for the 510K associated with the device. The product is sold unlabeled.
Frequently asked questions
How many devices does Lucero Medical, LLC have in the registry?
The registry currently lists 3 devices for Lucero Medical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lucero Medical, LLC's devices?
Among its 3 most recently registered devices, Lucero Medical, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Lucero Medical, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Lucero Medical, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Lucero Medical, LLC?
FDA recall records list 2 recalls initiated by Lucero Medical, LLC, the most recent initiated on 15 Jul 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Lucero Medical, LLC in the registry?
The most recently registered devices listed for Lucero Medical, LLC include ENDURAMESH, MODEL 762.XXX, ENDURAMESH and Lucero Medical Cervical Cage System.