# K250554: prodisc® L Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Centinel Spine, LLC
- Decided: Apr 25, 2025 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 P070001 (2007). 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)
- K242869: prodisc® L Instruments, Centinel Spine, LLC (2024) Summary page 6.

## Indications for use
The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.

Source page: https://510kreport.com/device/K250554
Methodology: https://510kreport.com/methodology