FDA product code · Orthopedic · Class 2
PEK: Spinous Process Plate
PEK is FDA's product code for "Spinous Process Plate": a Class 2 device classified under 21 CFR 888.3050, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for PEK
Across 17 510(k) clearances under PEK decided from 2018-01-01 to 2026-10-06, the median was 64 days from FDA receipt to decision. Half took between 53 and 105 days, and 80% were decided within 119 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 53 |
| Median | 64 |
| 75th percentile | 105 |
| 80th percentile | 119 |
| 90th percentile | 186 |
| Slowest | 332 |
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.
PEK in the public FDA record
| 510(k) clearances, all years | 48 |
|---|---|
| Establishment listings | 115 |
| GUDID device identifiers | 1,313 |
Counts of records, not of devices or events. Adverse event reports for PEK 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 PEK
1 FDA recognized consensus standard cite PEK, among them ASTM F2624-12 (Reapproved 2020). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-280 ASTM F2624-12 (Reapproved 2020) — Standard Test Method for Static Dynamic and Wear Assessment of Extra-Discal Single Level Spinal Constructs
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.