510(k) · Cleared
ClearedSEA-LINK Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Indius Medical Technologies Pvt., Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 24, 2020 as substantially equivalent to K070775 (Globus Medical, Inc., 2007) and 1 other predicate after a 55-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Mar 24, 2020
- Review
- 55 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K953730 (1995). 10 ancestors in all, the oldest K926453 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 3 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 2 generations backK052552 Hybrid Anterior Cervical Plate SystemDepuy Spine, Inc. · 2005 · Recalled
- 1 generation backK103491 Skyline Anterior Cervical Plate SystemA Johnson & Johnson Company · 2011
- This deviceK200224 SEA-LINK Anterior Cervical Plate SystemIndius Medical Technologies Pvt., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −3 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −2 | K052552 | Hybrid Anterior Cervical Plate System | Depuy Spine, Inc. | 2005 | 7 |
| −1 | K103491 | Skyline Anterior Cervical Plate System | A Johnson & Johnson Company | 2011 | — |
| 0 (this device) | K200224 | SEA-LINK Anterior Cervical Plate System | Indius Medical Technologies Pvt., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070775 | Modification to: Providence Anterior Cervical Plate SystemSummary page 5…Trade or Proprietary or Manufacturer Predicate Model Name Type K070775 Providence Anterior Globus Medical Inc. Primary Cervical Plate… | 2007 |
| * | K103491 | Skyline Anterior Cervical Plate SystemSummary page 5…Type K070775 Providence Anterior Globus Medical Inc. Primary Cervical Plate System K103491 Skyline Anterior Cervical A Johnson & Johnson Additional Plate Syste… | 2011 |
| Kept off the family tree | K134104 | Terrace™ Anterior Cervical Plate System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5…tem K103491 Skyline Anterior Cervical A Johnson & Johnson Additional Plate System Company K134104 Terrace™ Anterior Cervical CoreLink, LLC Additional Plate Syste… |
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 25 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 7 other devices also cite its predicate K070775.
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. 2020, this device’s year, is highlighted.
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 SEA-LINK Anterior Cervical Plate System is intended for temporary stabilization of the anterior cervical spine (C2-C7) during the development of cervical spinal fusion achieved through ACDF (Anterior Cervical Discectomy & Fusion) or corpectomy in patients with:
•Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
•Trauma (including fractures)
•Tumors
•Deformity defined as kyphosis, lordosis or scoliosis
•Pseudarthrosis
•Failed Previous Fusions
•Spondylolisthesis
•Spinal Stenosis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200224 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200224: SEA-LINK Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200224
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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