HPZ — Implant, Eye Sphere Class II
FDA product code HPZ covers "Implant, Eye Sphere", a Class II medical device regulated under 21 CFR 886.3320. Submissions are reviewed by the Ophthalmic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HPZ
- Device Class
- Class II
- Regulation Number
- 886.3320
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K212741 | fci (france chirurgie instrumentation) | EZYPOR | June 24, 2022 |
| K123764 | oculo-plastik | DURETTE OCULAR IMPLANT | January 31, 2013 |
| K110554 | ceramisys | BIOCERAMIC ORBITAL IMPLANT, ORBTEX | November 2, 2011 |
| K112176 | oculo plastik | SILICONE SPHERES | September 15, 2011 |
| K083342 | evera medical | ORBITAL RECONSTRUCTIVE IMPLANT II | March 12, 2009 |
| K082850 | product and educational services | EYE SPHERES | February 27, 2009 |
| K073293 | oculo plastik | DURETTE IMPLANT | March 19, 2008 |
| K071335 | porex surgical | MEDPOR ATTRACTOR IMPLANT | August 8, 2007 |
| K070130 | becker and associates consulting | ORBITAL RECONSTRUCTIVE IMPLANT | April 19, 2007 |
| K053298 | hydron pty limited | ALPHASPHERE ORBITAL IMPLANT | May 9, 2006 |
| K040851 | porex surgical | MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM | July 16, 2004 |
| K040689 | oculo plastik | EYE SPHERE IMPLANTS | June 10, 2004 |
| K023400 | fci ophthalmics | FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT | August 22, 2003 |
| K021643 | laboratoire villanova | HA ORBITAL IMPLANT | December 13, 2002 |
| K021357 | porex surgical | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT | August 5, 2002 |
| K010902 | porex surgical | MEDPOR QUAD MOTILITY IMPLANT | June 19, 2001 |
| K003338 | integrated orbital implants | BIO-EYE II ORBITAL IMPLANT | February 7, 2001 |
| K992294 | fci ophthalmics | BIOCERAMIC ORBITAL IMPLANT | April 19, 2000 |
| K982562 | integrated orbital implants | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER | December 28, 1998 |
| K972143 | iop | MOA BONE / M-SPHERE | October 16, 1997 |