← Product Code [KWI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI) · K944507

# METALLIC RADIAL HEAD IMPLANTS (K944507)

_Wrightmedicaltechnologyinc · KWI · Jul 13, 1995 · Orthopedic · SN_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K944507

## Device Facts

- **Applicant:** Wrightmedicaltechnologyinc
- **Product Code:** [KWI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI.md)
- **Decision Date:** Jul 13, 1995
- **Decision:** SN
- **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/K944507](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K944507)

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