Spivey-Allen Orbital Floor Implant
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K900930 FDA 510(k)
- FDA Product Code
- HQX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.3340 FDA 510(k)
- Regulation Number
- 886.3340 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Spivey-Allen Orbital Floor Implant is an extra-ocular orbital implant classified under FDA Product Code HQX. This device is designed as a non-absorbable implant intended for use during scleral surgery to provide structural support or reinforcement to the orbital floor, typically in retinal reattachment procedures.
The implant is supplied sterile and intended for single-use. It is regulated as a Class II medical device under 21 CFR 886.3340, with FDA clearance via a 510(k) submission (K900930) determined to be substantially equivalent. Available in multiple sizes, the implant is implanted surgically and requires sterile handling and storage as per standard ophthalmic surgical protocols.
Frequently asked questions
What is the Spivey-Allen Orbital Floor Implant primarily used for in surgical procedures?
The Spivey-Allen Orbital Floor Implant is designed to provide structural support or reinforcement to the orbital floor during scleral surgery, particularly in retinal reattachment procedures. It is intended to help stabilize the orbital floor when additional stability is required, ensuring proper positioning and function of the eye.
Is the Spivey-Allen Orbital Floor Implant intended for single-use or can it be reused?
The Spivey-Allen Orbital Floor Implant is explicitly supplied sterile and intended for single-use only. This aligns with standard ophthalmic surgical protocols, where single-use implants minimize infection risks and ensure patient safety.
How many sizes are available for the Spivey-Allen Orbital Floor Implant, and how are they identified?
The Spivey-Allen Orbital Floor Implant is available in multiple sizes, though exact dimensions are not specified in the data. These sizes are likely differentiated by unique registration numbers (e.g., 1218813, 3002991496, etc.) and may correspond to varying orbital floor anatomies. The manufacturer’s packaging or catalog would detail specific measurements.
What storage and handling precautions should be taken for the Spivey-Allen Orbital Floor Implant?
Since the implant is supplied sterile and intended for single-use, it must be stored in a sterile, sealed packaging until use. Handling should follow standard ophthalmic surgical protocols to maintain sterility, including avoiding contamination and adhering to expiration dates. The implant requires surgical implantation, so sterile field protocols must be strictly observed.
How was the Spivey-Allen Orbital Floor Implant approved by the FDA, and what does that mean for its use?
The implant received FDA clearance via a 510(k) submission (K900930), determined to be *substantially equivalent* to a predicate device. This means the FDA reviewed it as a Class II medical device under 21 CFR 886.3340 and confirmed it meets safety and effectiveness standards for its intended use in orbital floor reinforcement during scleral surgery. The clearance does not imply broader indications beyond what is described in the device’s labeling.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SPIVEY-ALLEN ORBITAL FLOOR IMPLANT (K900930) — FDA 510 (k) | Innolitics, Spivey-allen Orbital Floor Implant - Beudamed, HQX · Implant, Orbital, Extra-Ocular — FDA Product Code | Innolitics, HQX - Implant, Orbital, Extra-Ocular | FDA Product Code: Class II, 21 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K900930 | Class II | Active |
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Manufacturer
- Manufacturer
- Oculo-Plastik Inc
- FDA Applicant
- Oculo Plastik, Inc.
Sources (1)
- FDA 510(k) K900930 24 fields · synced Sep 19, 2026