21 CFR 888.3730 — Prosthesis, Toe, Hemi-, Phalangeal
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3730
Identification
A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 2 | 46 | Implant |