Class Class II
NITRO Interbody Fusion Cage System Family (K220513)
Description
NITRO Interbody Fusion Cage System Family by Ctl Medical Corporation, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK220513
Clearance Date2023-04-25
Clearance TypeTraditional
Product CodeODP
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220513
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. NITRO Interbody Fusion Cage System Family (K220513) cites 8 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192863 | MONDRIAN Lumbar Interbody Fusion Cage System | Ctl Medical Corporation | 2020 |
| K182151 | MONET Anterior Cervical Interbody Fusion Cage System with S... | Ctl Medical Corporation | 2018 |
| K172788 | MONET™ Anterior Cervical Interbody Fusion Cage System | Ctl Medical Corporation | 2018 |
| K172212 | MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-... | Ctl Medical Corporation | 2018 |
| K162682 | MATISSE Anterior Cervical Interbody Fusion Cage System | Ctl Medical Corporation | 2017 |
| K161405 | Valeo II Interbody Fusion Device System | Amedica Corp. | 2016 |
| K143518 | Valeo Spacer System and Valeo II Interbody Fusion Device Sy... | Amedica Corp. | 2015 |
| K121569 | MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM | Accel Spine | 2012 |
Trace the full predicate network for K220513
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.