510(k) K921106
- Device
- STERILE/SINGLE USE EYE SPHERE IMPLANTS
- Applicant
- STORZ INSTRUMENT CO.
- 510(k) number
- K921106
- Product code
- HPZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-03-30
- Date received
- 1992-03-09
- Regulation
- 886.3320
- Classification name
- Implant, Eye Sphere
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANET LACAVICH
- Address
- 3365 Tree Ct. Industrial Blvd. St. Louis MO US 63122 63122
FDA Registration Numbers#
- 1018470
- 3004467263
- 1058584
- 3004215117
- 2518410
- 2031962
- 3005528784
- 2027377
- 8010177
- 2028523
- 2245590
- 1225124
- 3015177648
- 3007708799
- 3010162973
- 1000286794
- 3002991496
- 9615745
- 2242450
Source Documents#
Other 510(k) Records For Product Code HPZ #
| 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 |
Legacy Summary#
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FDA Review#
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