Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QLQ — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
178 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253392 | Synergy Disc Instruments | Synergy Spine Solutions, Inc. | 2026-03-27 | 178 | 0 |
| K250554 | prodisc® L Instruments | Centinel Spine, LLC | 2025-04-25 | 59 | 0 |
| K242869 | prodisc® L Instruments | Centinel Spine, LLC | 2024-12-17 | 88 | 0 |
| K241117 | M6-C™ Single Use, Disposable Instrumentation | Spinal Kinetics / Orthofix / Seaspine | 2024-06-21 | 59 | 0 |
| K231769 | activL® Next Generation Instrumentation | Aesculap Implants Systems, LLC | 2023-07-13 | 27 | 0 |
| K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments | Centinel Spine, LLC | 2022-08-19 | 56 | 0 |
| K220861 | M6-C Artificial Cervical Disc Instruments AS | Spinal Kinetics, LLC | 2022-06-02 | 70 | 0 |
| K211757 | Simplify Disc | Nuvasive, Inc. | 2021-08-20 | 74 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda