FDA product code KWQ: Appliance, Fixation, Spinal Intervertebral Body
KWQ is the FDA product code for appliance, fixation, spinal intervertebral body. It is a Class II device, regulated under 21 CFR 888.3060 and reviewed by the Orthopedic panel. FDA has cleared 667 510(k) submissions under KWQ, 67 in the last five years, from 280 different applicants. The average 510(k) review took 111 days (median 84); 99 days on average over the last three years. FDA has posted 214 recalls for KWQ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class II |
| Regulation | 21 CFR 888.3060 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KWQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 20 | 104 |
| 2018 | 22 | 104 |
| 2019 | 26 | 90 |
| 2020 | 26 | 63 |
| 2021 | 17 | 82 |
| 2022 | 18 | 134 |
| 2023 | 16 | 80 |
| 2024 | 17 | 115 |
| 2025 | 7 | 73 |
| 2026 | 9 | 108 |
Compare with all 510(k) review times · Search every KWQ clearance
Top KWQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nuvasive, Inc. | 21 | 2013-11-27 |
| Globus Medical, Inc. | 15 | 2024-01-25 |
| K2m, Inc. | 15 | 2019-05-15 |
| Blackstone Medical, Inc. | 13 | 2010-05-04 |
| Medtronic Sofamor Danek | 13 | 2008-08-15 |
275 more applicants have KWQ clearances. See the full list in Caduvo.
Most recent KWQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261309 | Bethesda Medical Devices, LLC | Palisades Buttress Plate System | 2026-07-16 | 86 |
| K252776 | ZheJiang Decans Medical Devices Co., Ltd. | ARIES Anterior Cervical Plate Systems | 2026-05-14 | 254 |
| K261112 | L&K BIOMED Co., Ltd. | CastleLoc-P Anterior Cervical Plate System | 2026-05-06 | 33 |
| K260570 | Carlsmed, Inc. | corra cervical plating system | 2026-04-22 | 62 |
| K260697 | Vy Spine, LLC | VyPlate Anterior Cervical Plate System | 2026-03-27 | 23 |
Recalls for KWQ devices
214 product recalls in 50 recall events; 1 initiated in the last five years and 42 still open. Most recent: 2026-02-20.
| Year | Recalls |
|---|---|
| 2017 | 10 |
| 2018 | 2 |
| 2020 | 1 |
| 2021 | 70 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code KWQ?
KWQ is the FDA product code for appliance, fixation, spinal intervertebral body. It is a Class II device, regulated under 21 CFR 888.3060 and reviewed by the Orthopedic panel.
What device class is KWQ?
Class II, regulation 21 CFR 888.3060. Typical premarket route: 510(k).
How long does a 510(k) take for product code KWQ?
Across 667 cleared submissions the average was 111 days from receipt to decision (median 84).
Which companies have the most KWQ clearances?
Nuvasive, Inc. (21); Globus Medical, Inc. (15); K2m, Inc. (15); Blackstone Medical, Inc. (13); Medtronic Sofamor Danek (13).
Have KWQ devices been recalled?
Yes: 214 product recalls across 50 recall events; the most recent began 2026-02-20.
Next steps
- Run an FDA pathway report with predicate devices for product code KWQ
- Run a recall and safety report across every KWQ manufacturer
- Watch product code KWQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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