FDA product code · Orthopedic · Class 2
NKG: Posterior Cervical Screw System
NKG is FDA's product code for "Posterior Cervical Screw System": a Class 2 device classified under 21 CFR 888.3075, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for NKG
Across 71 510(k) clearances under NKG decided from 2018-01-01 to 2026-10-06, the median was 59 days from FDA receipt to decision. Half took between 35 and 107 days, and 80% were decided within 119 days. These are past clearances, not a forecast for a new submission.
| Fastest | 6 |
|---|---|
| 25th percentile | 35 |
| Median | 59 |
| 75th percentile | 107 |
| 80th percentile | 119 |
| 90th percentile | 236 |
| Slowest | 431 |
| Year | Median days | n |
|---|---|---|
| 2018 | 61 | 12 |
| 2019 | 50 | 8 |
| 2020 | 59 | 14 |
| 2021 | 56 | 7 |
| 2022 | 108 | 7 |
| 2023 | 58 | 10 |
| 2025 | 58 | 6 |
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.
NKG in the public FDA record
| 510(k) clearances, all years | 118 |
|---|---|
| Establishment listings | 450 |
| GUDID device identifiers | 23,433 |
Counts of records, not of devices or events. Adverse event reports for NKG 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 NKG
8 FDA recognized consensus standards cite NKG, among them ASTM F2706-18; ASTM F3292-19; ASTM F2193-20. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-346 ASTM F2706-18 — Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
- 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
- 11-435 ASTM F3292-25 — Standard Practice for Inspection of Spinal Implants Undergoing Testing
- 11-443 ASTM F2706-25 — Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.