← Product Code [KWI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI) · K885146

# CL UNIVERSAL HIP DEVICE (K885146)

_Lima Intl. Corp. · KWI · Apr 24, 1989 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K885146

## Device Facts

- **Applicant:** Lima Intl. Corp.
- **Product Code:** [KWI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI.md)
- **Decision Date:** Apr 24, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3170
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K885146](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K885146)

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