510(k) · Cleared
ClearedEbi Spinelink Anterior Cervical Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 12, 2002 as substantially equivalent to K973923 (Ebi Electro Biology, 1998) and 3 other predicates after a 19-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Aug 12, 2002
- Review
- 19 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K973923 (1998). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK973923 Ebi Spinelink Anterior Cervical Spinal SystemEbi Electro Biology · 1998
- This deviceK022419 Ebi Spinelink Anterior Cervical Spinal SystemEbi, L.P. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973923 | Ebi Spinelink Anterior Cervical Spinal System | Ebi Electro Biology | 1998 | — |
| 0 (this device) | K022419 | Ebi Spinelink Anterior Cervical Spinal System | Ebi, L.P. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
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 KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K973923 | Ebi Spinelink Anterior Cervical Spinal SystemSummary page 1…ntervertebral Body Fixation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: + EBI@SpineLinkTMAnterior Cervical Spinal System (K973923, K99 1092, K993 822, KO005 13) 4. Description of the device: The EBI SpineLink System is an anterior cervical spina… | 1998 |
| * | K991092 | Ebi Spinelink Anterior Cervical Spinal SystemSummary page 1…bral Body Fixation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: + EBI@SpineLinkTMAnterior Cervical Spinal System (K973923, K99 1092, K993 822, KO005 13) 4. Description of the device: The EBI SpineLink System is an anterior cervical spinal fixation… | 1999 |
| * | K993822 | Ebi Spinelink Anterior Cervical Spinal SystemSummary page 1…n Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: + EBI@SpineLinkTMAnterior Cervical Spinal System (K973923, K99 1092, K993 822, KO005 13) 4. Description of the device: The EBI SpineLink System is an anterior cervical spinal fixation device that uses… | 1999 |
| * | K000513 | Modification to Ebi Spinelink Anterior Cervical Spinal System | 2000 |
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?
- None of the 4 ancestors has a recall.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The EBI@SpineLinkTMAnterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including…
Read the full statement (101 words)
The EBI@SpineLinkTMAnterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fiactures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
Warning: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022419: Ebi Spinelink Anterior Cervical Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022419
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026