← Product Code [KYJ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ) · K781668

# GAMMA RADIATION STERILIZATION PRECEDURE (K781668)

_Cutter Laboratories, Inc. · KYJ · Nov 3, 1978 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K781668

## Device Facts

- **Applicant:** Cutter Laboratories, Inc.
- **Product Code:** [KYJ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ.md)
- **Decision Date:** Nov 3, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3230
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K781668](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K781668)

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