Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3500](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3500) → KDA — Prosthesis, Ptfe/Carbon-Fiber

# KDA · Prosthesis, Ptfe/Carbon-Fiber

_General, Plastic Surgery · 21 CFR 878.3500 · Class 2_

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

## Overview

- **Product Code:** KDA
- **Device Name:** Prosthesis, Ptfe/Carbon-Fiber
- **Regulation:** [21 CFR 878.3500](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3500)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## Identification

A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K861806](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KDA/K861806.md) | MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT) | Medcomp Technologies, Inc. | May 23, 1986 | SESE |

## Top Applicants

- Medcomp Technologies, Inc. — 1 clearance

---

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

**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