FDA product code · Orthopedic · Class 2
PLF: Bone Wedge
PLF is FDA's product code for "Bone Wedge": a Class 2 device classified under 21 CFR 888.3030, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for PLF
Across 14 510(k) clearances under PLF decided from 2018-01-01 to 2026-10-06, the median was 89 days from FDA receipt to decision. Half took between 34 and 158 days, and 80% were decided within 185 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 34 |
| Median | 89 |
| 75th percentile | 158 |
| 80th percentile | 185 |
| 90th percentile | 266 |
| Slowest | 395 |
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.
PLF in the public FDA record
| Device recalls | 9 |
|---|---|
| GUDID device identifiers | 404 |
Counts of records, not of devices or events. Adverse event reports for PLF 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 PLF
1 FDA recognized consensus standard cite PLF, among them ASTM F2077-24. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-421 ASTM F2077-24 — Standard Test Methods for Intervertebral Body Fusion Devices
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.