FDA product code · Orthopedic · Class 2
KWQ: Appliance, Fixation, Spinal Intervertebral Body
KWQ is FDA's product code for "Appliance, Fixation, Spinal Intervertebral Body": a Class 2 device classified under 21 CFR 888.3060, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for KWQ
Across 159 510(k) clearances under KWQ decided from 2018-01-01 to 2026-10-06, the median was 64 days from FDA receipt to decision. Half took between 48 and 107 days, and 80% were decided within 124 days. These are past clearances, not a forecast for a new submission.
| Fastest | 9 |
|---|---|
| 25th percentile | 48 |
| Median | 64 |
| 75th percentile | 107 |
| 80th percentile | 124 |
| 90th percentile | 228 |
| Slowest | 450 |
| Year | Median days | n |
|---|---|---|
| 2018 | 95 | 22 |
| 2019 | 81 | 26 |
| 2020 | 55 | 26 |
| 2021 | 59 | 17 |
| 2022 | 85 | 18 |
| 2023 | 59 | 16 |
| 2024 | 64 | 17 |
| 2025 | 64 | 7 |
| 2026 (to 10-06, partial) | 76 | 10 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
KWQ in the public FDA record
| 510(k) clearances, all years | 667 |
|---|---|
| Device recalls | 214 |
| Establishment listings | 4,349 |
| GUDID device identifiers | 172,710 |
Counts of records, not of devices or events. Adverse event reports for KWQ are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite KWQ
11 FDA recognized consensus standards cite KWQ, among them ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018); ASTM F3292-19. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-197 ASTM F983-86 (Reapproved 2018) — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-199 ASTM F565-04 (Reapproved 2018) — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 11-369 ASTM F3292-19 — Standard Practice for Inspection of Spinal Implants Undergoing Testing
- 11-375 ASTM F2193-20 — Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
- 11-388 ASTM F1717-21 — Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- 11-402 ASTM F1798-21 — Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- 11-422 ASTM F1798-24 — Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- 11-424 ASTM F983-24 — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-425 ASTM F565-21 — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 11-435 ASTM F3292-25 — Standard Practice for Inspection of Spinal Implants Undergoing Testing
- 8-558 ASTM F3333-20 — Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.