← Product Code [KWY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY) · K833404

# BDH BIPOLAR FEMORAL COMPONENT A3 (K833404)

_Carbomedics, Inc. · KWY · Mar 2, 1984 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K833404

## Device Facts

- **Applicant:** Carbomedics, Inc.
- **Product Code:** [KWY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY.md)
- **Decision Date:** Mar 2, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3390
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K833404](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K833404)

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