← Product Code [JEY](/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY) · K010352

# CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM (K010352)

_Inion , Ltd. · JEY · Mar 14, 2001 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K010352

## Device Facts

- **Applicant:** Inion , Ltd.
- **Product Code:** [JEY](/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY.md)
- **Decision Date:** Mar 14, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4760
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K010352](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K010352)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com