# K241117: M6-C™ Single Use, Disposable Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Kinetics / Orthofix / Seaspine
- Decided: Jun 21, 2024 after 59 days
- Product code: QLQ (Manual Instruments Designed For Use With Total Disc Replacement Devices)
- Device class: 2
- Regulation: 21 CFR 888.4515
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P200022 (2020). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220861: M6-C Artificial Cervical Disc Instruments AS, Spinal Kinetics, LLC (2022) Summary page 4.

## Indications for use
The M6-C™ Single Use, Disposable Instrumentation are intended for the placement and positioning of the M6-C Artificial Cervical Disc.

Source page: https://510kreport.com/device/K241117
Methodology: https://510kreport.com/methodology