← Product Code [KWD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD) · K781870

# IMPLANT, H.P. CONDYLAR (K781870)

_Dow Corning Corp. Healthcare Industries Materials · KWD · Feb 9, 1979 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K781870

## Device Facts

- **Applicant:** Dow Corning Corp. Healthcare Industries Materials
- **Product Code:** [KWD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD.md)
- **Decision Date:** Feb 9, 1979
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K781870](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K781870)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
