Code of Federal Regulations (Last Updated: July 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 888 - Orthopedic Devices |
Subpart D - Prosthetic Devices |
§ 888.3230 - Finger joint polymer constrained prosthesis.
Latest version.
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§ 888.3230 Finger joint polymer constrained prosthesis.
(a) 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.
(b) Classification. Class II.