TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) (K223108)
Description
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) by Medos International SARL, an FDA 510(k) cleared neurology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223108
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. TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) (K223108) cites 4 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213978 | TELIGEN System | Medos International SARL | 2022 |
| K212756 | Discectomy Navigation Ready Instruments and Universal Navig... | Medos International SARL | 2022 |
| K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navig... | Brainlab AG | 2022 |
| K122211 | SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS | Synthes Spine | 2012 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233254 | TELIGEN System Navigation Ready Instruments | DePuy Synthes | 2024 |
| K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indications | Medos International SARL | 2023 |
Trace the full predicate network for K223108
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.