Product code HPZ
- Device name
- Implant, Eye Sphere
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.3320
- Review panel
- OP
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212741 | EZYPOR | Fci (France Chirurgie Instrumentation) Sas | 2022-06-24 |
| K123764 | DURETTE OCULAR IMPLANT | Oculo-Plastik, Inc. | 2013-01-31 |
| K110554 | BIOCERAMIC ORBITAL IMPLANT, ORBTEX | Ceramisys, Ltd. | 2011-11-02 |
| K112176 | SILICONE SPHERES | Oculo Plastik, Inc. | 2011-09-15 |
| K083342 | ORBITAL RECONSTRUCTIVE IMPLANT II | Evera Medical, Inc. | 2009-03-12 |
| K082850 | EYE SPHERES | Product and Educational Services, LLC | 2009-02-27 |
| K073293 | DURETTE IMPLANT | Oculo Plastik, Inc. | 2008-03-19 |
| K071335 | MEDPOR ATTRACTOR IMPLANT | Porex Surgical, Inc. | 2007-08-08 |
| K070130 | ORBITAL RECONSTRUCTIVE IMPLANT | Becker & Associates Consulting, Inc. | 2007-04-19 |
| K053298 | ALPHASPHERE ORBITAL IMPLANT | Hydron Pty Limited | 2006-05-09 |
| K040851 | MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM | Porex Surgical, Inc. | 2004-07-16 |
| K040689 | EYE SPHERE IMPLANTS | Oculo Plastik, Inc. | 2004-06-10 |
| K023400 | FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT | Fci Ophthalmics, Inc. | 2003-08-22 |
| K021643 | HA ORBITAL IMPLANT | Laboratoire Villanova | 2002-12-13 |
| K021357 | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT | Porex Surgical, Inc. | 2002-08-05 |
| K010902 | MEDPOR QUAD MOTILITY IMPLANT | Porex Surgical, Inc. | 2001-06-19 |
| K003338 | BIO-EYE II ORBITAL IMPLANT | Integrated Orbital Implants, Inc. | 2001-02-07 |
| K992294 | BIOCERAMIC ORBITAL IMPLANT | Fci Ophthalmics, Inc. | 2000-04-19 |
| K982562 | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER | Integrated Orbital Implants, Inc. | 1998-12-28 |
| K972143 | MOA BONE / M-SPHERE | Iop, Inc. | 1997-10-16 |
| K972661 | EYE SPHERE, CONFORMERS | Gulden Ophthalmics | 1997-10-03 |
| K962241 | GORE SPHEREX IMPLANT | W. L. Gore & Associates, Inc. | 1996-08-22 |
| K960859 | MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES | Porex Technologies Corp. of Georgia | 1996-05-29 |
| K954939 | MEDPOR OCULAR SCREW & ACCESSORIES | Porex Surgical, Inc. | 1996-01-25 |
| K941717 | MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT | Miguel Martinez M.D. | 1995-02-14 |
| K943275 | MEDPOR SURGICAL IMPLANT MATERIAL | Porex Surgical, Inc. | 1994-09-02 |
| K934834 | EPTFE SHEET COVERING FOR OCULAR IMPLANT | Oculo Plastik, Inc. | 1994-05-05 |
| K935251 | MARTINEZ ORBITAL IMPLANT | Miguel Martinez M.D. | 1994-03-01 |
| K921106 | STERILE/SINGLE USE EYE SPHERE IMPLANTS | Storz Instrument Co. | 1992-03-30 |
| K915630 | OPHTIMPLANT | Oculo Plastik, Inc. | 1992-03-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10697660000173 | Silicone Spheres (15 mm, 1.8 cc) | Oculo-Plastik Inc | 2019-10-17 |
| 10697660000388 | Durette #1, PMMA (20 mm, 4.0 cc) | Oculo-Plastik Inc | 2019-10-17 |
| 10697660000418 | Durette #4, PMMA (20 mm, 3.5 cc) | Oculo-Plastik Inc | 2019-10-17 |
| 10697660000159 | Silicone Spheres (14 mm , 1.4 cc) | Oculo-Plastik Inc | 2019-10-17 |
| 10697660000326 | Acrylic Spheres 14 mm, 1.5 cc | Oculo-Plastik Inc | 2019-10-15 |
| 10697660000340 | Acrylic Spheres 18 mm, 2.8 cc | Oculo-Plastik Inc | 2019-10-15 |
| 10697660000357 | Acrylic Spheres 20 mm, 3.6 cc | Oculo-Plastik Inc | 2019-10-15 |
| 10697660000364 | Acrylic Spheres 22 mm, 5.7 cc | Oculo-Plastik Inc | 2019-10-15 |
| M8721122101 | Silicone Spheres (21 mm, 4.8 cc) | Oculo-Plastik Inc | 2016-10-16 |
| M87211222V9 | Silicone Spheres (22 mm, 5.6 cc) In Bulk | Oculo-Plastik Inc | 2016-10-16 |
| M87211221V9 | Silicone Spheres (21 mm, 4.8 cc) In Bulk | Oculo-Plastik Inc | 2016-10-16 |
| M87211220V9 | Silicone Spheres (20 mm, 4.2 cc) In Bulk | Oculo-Plastik Inc | 2016-10-16 |
| M87211219V95 | Silicone Spheres (19 mm, 3.6 cc) In Bulk | Oculo-Plastik Inc | 2016-10-16 |
| M87211216V92 | Silicone Spheres (16 mm, 2.1 cc) In Bulk | Oculo-Plastik Inc | 2016-10-16 |
| M87211215V91 | Silicone Spheres (15 mm, 1.8 cc) In Bulk | Oculo-Plastik Inc | 2016-10-16 |
| M87211214V90 | Silicone Spheres (14 mm, 1.4 cc) In Bulk | Oculo-Plastik Inc | 2016-10-16 |
| M87211212V9 | Silicone Spheres (12 mm, 0.9cc) In Bulk | Oculo-Plastik Inc | 2016-10-16 |
| M87211218V94 | Silicone Spheres (18 mm, 3.1 cc) | Oculo-Plastik Inc | 2016-10-16 |
| 00854066006113 | Bio-Eye® | INTEGRATED ORBITAL IMPLANTS INC | 2015-12-01 |
| 00854066006106 | Bio-Eye® | INTEGRATED ORBITAL IMPLANTS INC | 2015-12-01 |
| 00854066006090 | Bio-Eye® | INTEGRATED ORBITAL IMPLANTS INC | 2015-12-01 |
| 00854066006083 | Bio-Eye® | INTEGRATED ORBITAL IMPLANTS INC | 2015-12-01 |
| 00854066006076 | Bio-Eye® | INTEGRATED ORBITAL IMPLANTS INC | 2015-12-01 |
| 00854066006069 | Bio-Eye® | INTEGRATED ORBITAL IMPLANTS INC | 2015-12-01 |
| 00854066006052 | Bio-Eye® | INTEGRATED ORBITAL IMPLANTS INC | 2015-12-01 |
| 00854066006045 | Bio-Eye® | INTEGRATED ORBITAL IMPLANTS INC | 2015-12-01 |
| 00854066006038 | Bio-Eye® | INTEGRATED ORBITAL IMPLANTS INC | 2015-12-01 |
| 00854066006021 | Bio-Eye® | INTEGRATED ORBITAL IMPLANTS INC | 2015-12-01 |
| 00854066006014 | Bio-Eye® | INTEGRATED ORBITAL IMPLANTS INC | 2015-12-01 |
| 00854066006007 | Bio-Eye® | INTEGRATED ORBITAL IMPLANTS INC | 2015-12-01 |