← Product Code [KWD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD) · K875249

# SUTTER PHALANGEAL CAP (K875249)

_Sutter Biomedical, Inc. · KWD · Feb 3, 1988 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K875249

## Device Facts

- **Applicant:** Sutter Biomedical, Inc.
- **Product Code:** [KWD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD.md)
- **Decision Date:** Feb 3, 1988
- **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/K875249](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K875249)

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