Implant, Orbital, Extra-Ocular
An Extra-Ocular Orbital Implant is a surgically implanted device placed in the orbital cavity, typically following enucleation or evisceration, to restore orbital volume, maintain socket anatomy, and provide support for an ocular prosthesis and normal eyelid position. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HQX and is regulated under 21 CFR 886.3340, within the Ophthalmic medical specialty. It is classified as an implant.
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Basic Information
- Product Code
- HQX
- Device Class
- FDA class 2
- Regulation Number
- 886.3340
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K023481 | MICROVISION SCLERAL BUCKLING COMPONENTS | Jan 08, 2003 | Substantially Equivalent | Microvision, Inc. |
| K983581 | OCU-GUARD AND OCU-GUARD SUPPLE | Nov 06, 1998 | Substantially Equivalent | Bio-Vascular, Inc. |
| K980816 | RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES | Sep 18, 1998 | Substantially Equivalent | Fci Ophthalmics, Inc. |
| K963219 | RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES | Oct 28, 1996 | Substantially Equivalent | Fci Ophthalmics, Inc. |
| K950806 | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS | Jun 05, 1996 | Substantially Equivalent | Mira, Inc. |
| K950599 | STORS SCLERAL SPONGE II (LINCOFF DESIGN) | Mar 02, 1995 | Substantially Equivalent | Storz Ophthalmics, Inc. |
| K945172 | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS | Jan 17, 1995 | Substantially Equivalent | Visitec Co. |
| K902308 | TAMCENAN OCULAR EXPLANTS AND BANDS | Jun 19, 1990 | Substantially Equivalent | Tamcenan Corp. |
| K901002 | O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES | May 22, 1990 | Substantially Equivalent | Oculo Plastik, Inc. |
| K900929 | PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL | May 18, 1990 | Substantially Equivalent | Oculo Plastik, Inc. |
| K900930 | SPIVEY-ALLEN ORBITAL FLOOR IMPLANT | May 15, 1990 | Substantially Equivalent | Oculo Plastik, Inc. |
| K900928 | COX MALAR EMINENCE IMPLANTS | May 15, 1990 | Substantially Equivalent | Oculo Plastik, Inc. |
| K900927 | CODERE-DURETTE ORBITAL FLOOR IMPLANT | May 15, 1990 | Substantially Equivalent | Oculo Plastik, Inc. |
| K863946 | POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT | Feb 27, 1987 | Substantially Equivalent | Porex Medical |
| K832481 | SCLERAL BUCKLING IMPLANTS DIF/TYPES | Sep 20, 1983 | Substantially Equivalent | Storz Instrument Co. |
| K800140 | SILASTIC SCLERAL SPONGE II W/CIRCLING BD | Mar 03, 1980 | Substantially Equivalent | Dow Corning Corp. Healthcare Industries Materials |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.