HPZ · Implant, Eye Sphere
Ophthalmic · 21 CFR 886.3320 · Class 2
Overview
| Product Code | HPZ |
|---|---|
| Device Name | Implant, Eye Sphere |
| Regulation | 21 CFR 886.3320 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| Implant | Yes |
Identification
An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
Classification Rationale
Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Recent Cleared Devices (20 of 39)
Showing 20 most recent of 39 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K212741 | EZYPOR | Fci (France Chirurgie Instrumentation) Sas | Jun 24, 2022 | SESE |
| K123764 | DURETTE OCULAR IMPLANT | Oculo-Plastik, Inc. | Jan 31, 2013 | SESE |
| K110554 | BIOCERAMIC ORBITAL IMPLANT, ORBTEX | Ceramisys, Ltd. | Nov 2, 2011 | SESE |
| K112176 | SILICONE SPHERES | Oculo Plastik, Inc. | Sep 15, 2011 | SESE |
| K083342 | ORBITAL RECONSTRUCTIVE IMPLANT II | Evera Medical, Inc. | Mar 12, 2009 | SESE |
| K082850 | EYE SPHERES | Product and Educational Services, LLC | Feb 27, 2009 | SESE |
| K073293 | DURETTE IMPLANT | Oculo Plastik, Inc. | Mar 19, 2008 | SESE |
| K071335 | MEDPOR ATTRACTOR IMPLANT | Porex Surgical, Inc. | Aug 8, 2007 | SESE |
| K070130 | ORBITAL RECONSTRUCTIVE IMPLANT | Becker & Associates Consulting, Inc. | Apr 19, 2007 | SESE |
| K053298 | ALPHASPHERE ORBITAL IMPLANT | Hydron Pty Limited | May 9, 2006 | SESE |
| K040851 | MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM | Porex Surgical, Inc. | Jul 16, 2004 | SESE |
| K040689 | EYE SPHERE IMPLANTS | Oculo Plastik, Inc. | Jun 10, 2004 | SESE |
| K023400 | FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT | Fci Ophthalmics, Inc. | Aug 22, 2003 | SESE |
| K021643 | HA ORBITAL IMPLANT | Laboratoire Villanova | Dec 13, 2002 | SESE |
| K021357 | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT | Porex Surgical, Inc. | Aug 5, 2002 | SESE |
| K010902 | MEDPOR QUAD MOTILITY IMPLANT | Porex Surgical, Inc. | Jun 19, 2001 | SESE |
| K003338 | BIO-EYE II ORBITAL IMPLANT | Integrated Orbital Implants, Inc. | Feb 7, 2001 | SESE |
| K992294 | BIOCERAMIC ORBITAL IMPLANT | Fci Ophthalmics, Inc. | Apr 19, 2000 | SESE |
| K982562 | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER | Integrated Orbital Implants, Inc. | Dec 28, 1998 | SESE |
| K972143 | MOA BONE / M-SPHERE | Iop, Inc. | Oct 16, 1997 | SESE |
Top Applicants
- Oculo Plastik, Inc. — 7 clearances
- Porex Surgical, Inc. — 6 clearances
- Integrated Orbital Implants, Inc. — 3 clearances
- Miguel Martinez M.D. — 2 clearances
- Fci Ophthalmics, Inc. — 2 clearances
