GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System (K230325)
Description
GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System by Greens Surgicals Pvt. , Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
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Predicate lineage for K230325
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. GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System (K230325) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K152457 | CD HORIZON Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 |
| K150896 | Vitality Spinal Fixation System | Zimmer Spine, Inc. | 2015 |
| K121342 | XIA 4.5 SPINAL SYSTEM | Stryker Corp. | 2012 |
Trace the full predicate network for K230325
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.