Silicone Spheres
FDA 510(k) K112176 · Oculo Plastik, Inc.
510(k) numberK112176
Submission
- Device name
- Silicone Spheres
- Applicant
- Oculo Plastik, Inc.
Montreal, Quebec, CA - Received
- July 28, 2011
- Decision date
- September 15, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HPZ – Implant, Eye Sphere
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3320
- Specialty
- Ophthalmic
- Implant
- Yes
Other 510(k)s with product code HPZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212741 | EzyporHPZ · Traditional | Fci (France Chirurgie Instrumentation) Sas | 06/24/2022SE |
| K123764 | Durette Ocular ImplantHPZ · Traditional | Oculo-Plastik, Inc. | 01/31/2013SE |
| K110554 | Bioceramic Orbital Implant, OrbtexHPZ · Traditional | Ceramisys, Ltd. | 11/02/2011SE |
| K083342 | Orbital Reconstructive Implant IIHPZ · Traditional | Evera Medical, Inc. | 03/12/2009SE |
| K082850 | Eye SpheresHPZ · Traditional | Product and Educational Services, LLC | 02/27/2009SE |
| K073293 | Durette ImplantHPZ · Traditional | Oculo Plastik, Inc. | 03/19/2008SE |
| K071335 | Medpor Attractor ImplantHPZ · Traditional | Porex Surgical, Inc. | 08/08/2007SE |
| K070130 | Orbital Reconstructive ImplantHPZ · Traditional | Becker & Associates Consulting, Inc. | 04/19/2007SE |
| K053298 | Alphasphere Orbital ImplantHPZ · Traditional | Hydron Pty Limited | 05/09/2006SE |
| K040851 | Medpor Attractor Magnetic Coupling SystemHPZ · Traditional | Porex Surgical, Inc. | 07/16/2004SE |
More from Porex Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K123764 | Durette Ocular ImplantHPZ · Traditional | 01/31/2013SE |
| K073293 | Durette ImplantHPZ · Traditional | 03/19/2008SE |
| K040689 | Eye Sphere ImplantsHPZ · Traditional | 06/10/2004SE |
| K934834 | Eptfe Sheet Covering for Ocular ImplantHPZ · Traditional | 05/05/1994SE |
| K915630 | OphtimplantHPZ · Traditional | 03/02/1992SE |
| K901002 | O'Donnell, Socket Reconstruction ProsthesesHQX · Traditional | 05/22/1990SE |
| K900929 | Putterman-Scott, Socket Reconstruction BilateralHQX · Traditional | 05/18/1990SE |
| K900930 | Spivey-Allen Orbital Floor ImplantHQX · Traditional | 05/15/1990SE |
| K900928 | Cox Malar Eminence ImplantsHQX · Traditional | 05/15/1990SE |
| K900927 | Codere-Durette Orbital Floor ImplantHQX · Traditional | 05/15/1990SE |
Questions and answers
When was Silicone Spheres cleared by the FDA?
Silicone Spheres (K112176) received a 510(k) decision of Substantially Equivalent on September 15, 2011, 49 days after the submission was received.
What is the product code of K112176?
The FDA product code is HPZ – Implant, Eye Sphere, a Class II (moderate risk) device regulated under 21 CFR 886.3320.