FDA product code · Orthopedic · Class 2
PLR: Spinal Vertebral Body Replacement Device - Cervical
PLR is FDA's product code for "Spinal Vertebral Body Replacement Device - Cervical": 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 PLR
Across 16 510(k) clearances under PLR decided from 2018-01-01 to 2026-10-06, the median was 238 days from FDA receipt to decision. Half took between 75 and 266 days, and 80% were decided within 271 days. These are past clearances, not a forecast for a new submission.
| Fastest | 57 |
|---|---|
| 25th percentile | 75 |
| Median | 238 |
| 75th percentile | 266 |
| 80th percentile | 271 |
| 90th percentile | 306 |
| Slowest | 314 |
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.
PLR in the public FDA record
| Establishment listings | 114 |
|---|---|
| GUDID device identifiers | 3,985 |
Counts of records, not of devices or events. Adverse event reports for PLR 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 PLR
1 FDA recognized consensus standard cite PLR, among them ASTM F2267-24. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-423 ASTM F2267-24 — Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.