Class Class II
G Surgical Marksman Spinal Deformity System (K230063)
Description
G Surgical Marksman Spinal Deformity System by G Surgical, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230063
Clearance Date2023-02-09
Clearance TypeSpecial
Product CodeNKB
Regulation Number888.3070
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230063
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. G Surgical Marksman Spinal Deformity System (K230063) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193219 | G Surgical Marksman System | G Surgical, LLC | 2019 |
| K161516 | G Surgical Marksman MIS System | G Surgical, LLC | 2016 |
| K081041 | GPS, G SURGICAL PEDICLE SYSTEM | G Surgical Co., Ltd. | 2008 |
Trace the full predicate network for K230063
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.