← Product Code [KYI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI) · K790508

# TRAPEZIO-METACARPAL JOINT SPACER (K790508)

_Scientific Data Systems Israel, Ltd. · KYI · Apr 10, 1979 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K790508

## Device Facts

- **Applicant:** Scientific Data Systems Israel, Ltd.
- **Product Code:** [KYI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI.md)
- **Decision Date:** Apr 10, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3770
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K790508](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K790508)

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