← Product Code [HQX](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX) · K900930

# SPIVEY-ALLEN ORBITAL FLOOR IMPLANT (K900930)

_Oculo Plastik, Inc. · HQX · May 15, 1990 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K900930

## Device Facts

- **Applicant:** Oculo Plastik, Inc.
- **Product Code:** [HQX](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX.md)
- **Decision Date:** May 15, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.3340
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K900930](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K900930)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com