21 CFR 886.3340 — Implant, Orbital, Extra-Ocular

Ophthalmic (OP) · Part 886 Subpart D—Prosthetic Devices · § 886.3340

Identification

An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
HQXImplant, Orbital, Extra-Ocular216Implant
Innolitics

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