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 CodeDevice NameClassDevicesAttributes
KWDProsthesis, Toe, Hemi-, Phalangeal246Implant
Innolitics

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