← Product Code [KWI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI) · K000658

# ERS RADIAL HEAD REPLACEMENT (K000658)

_DePuy Orthopaedics, Inc. · KWI · May 11, 2000 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K000658

## Device Facts

- **Applicant:** DePuy Orthopaedics, Inc.
- **Product Code:** [KWI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI.md)
- **Decision Date:** May 11, 2000
- **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/K000658](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K000658)

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