← Product Code [KWD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD) · K911378

# TOWNLEY GREAT TOE JOINT (K911378)

_Biopro, Inc. · KWD · Nov 22, 1991 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K911378

## Device Facts

- **Applicant:** Biopro, Inc.
- **Product Code:** [KWD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD.md)
- **Decision Date:** Nov 22, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3730
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K911378](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K911378)

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