# Spinous Process Plate
> **Product code: PEK** · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3050
## Classification
- **FDA Product Code:** PEK
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 888.3050
- **Review panel:** OR
- **Medical specialty:** Orthopedic
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1).  It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Trauma (i.e., fracture or dislocation), Spondylolisthesis, and/or Tumor.  It is not intended for stand-alone use.

## Market data
- **Cleared 510(k) submissions:** 48
- **Registered establishments:** 77
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PEK)
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