Class Class II
Galileo Vertebral Body Replacement Device (K221542)
Description
Galileo Vertebral Body Replacement Device by Bright Spine, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221542
Clearance Date2023-01-13
Clearance TypeSpecial
Product CodePLR
Regulation Number888.3060
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221542
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Galileo Vertebral Body Replacement Device (K221542) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192145 | Galileo Vertebral Body Replacement Device | Bright Spine | 2020 |
Trace the full predicate network for K221542
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.