510(k) · Cleared
ClearedBAGUERA® C Cervical Disc Surgical Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineart SA · QLQ Manual Instruments Designed For Use With Total Disc Replacement Devices
Cleared on Aug 14, 2026 as substantially equivalent to K221848 (Centinel Spine, LLC, 2022) after a 16-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Aug 14, 2026
- Review
- 16 days
- Class
- Class II
- Product code
- QLQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P070001 (2007). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QLQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QLQ device
- #1 K221848 prodisc C SK, prodisc C Nova, and prodisc C…score 12.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsSummary page 5…instruments from other manufacturers unless otherwise specified. Primary Predicate Device: Centinel Spine prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (K221848) Performance Testing: Testing included user testing, dimension analysis, cleaning validation, and steam sterilization. All comp… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 14.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K221848.
How does its category compare?
All QLQ devicesQLQ Manual Instruments Designed For Use With Total Disc Replacement Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QLQ
3so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QLQ
28in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QLQ
No recall names QLQ since 2007.
Adverse event reports per year · QLQ
2in 2022
MAUDE reports naming product code QLQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 3 | 28 | 0 | — |
What is it indicated for?
The BAGUERA C Cervical Disc Surgical Instruments are intended for the placement, positioning, and removal of the BAGUERA C Cervical Disc Prosthesis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K262639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262639: BAGUERA® C Cervical Disc Surgical Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262639
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026