FDA product code · Neurology · Class 2
GWO: Plate, Cranioplasty, Preformed, Alterable
GWO is FDA's product code for "Plate, Cranioplasty, Preformed, Alterable": a Class 2 device classified under 21 CFR 882.5320, reviewed by the Neurology panel. FDA flags it as an implant.
510(k) review time for GWO
Across 13 510(k) clearances under GWO decided from 2018-01-01 to 2026-10-06, the median was 170 days from FDA receipt to decision. Half took between 120 and 269 days, and 80% were decided within 280 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 120 |
| Median | 170 |
| 75th percentile | 269 |
| 80th percentile | 280 |
| 90th percentile | 340 |
| Slowest | 445 |
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.
GWO in the public FDA record
| 510(k) clearances, all years | 43 |
|---|---|
| Device recalls | 24 |
| GUDID device identifiers | 1,547 |
Counts of records, not of devices or events. Adverse event reports for GWO 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 GWO
No FDA recognized consensus standard cites GWO by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.