Fci Mesh Wrapped Bioceramic Orbital Implant
FDA 510(k) K023400 · Fci Ophthalmics, Inc.
510(k) numberK023400
Submission
- Device name
- Fci Mesh Wrapped Bioceramic Orbital Implant
- Applicant
- Fci Ophthalmics, Inc.
Centercille, MA, US - Received
- October 9, 2002
- Decision date
- August 22, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K112176 | Silicone SpheresHPZ · Special | Oculo Plastik, Inc. | 09/15/2011SE |
| 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 |
More from Hydron Pty Limited
| 510(k) | Device | Decision |
|---|---|---|
| K061404 | Mono-Crawford Naso-Lacrimal Intubation DeviceOKS · Traditional | 08/07/2006SE |
| K061398 | Snug Plug Punctum PlugLZU · Traditional | 07/11/2006SE |
| K041869 | Self Retaining Bicanaliculus Intubation SetOKS · Traditional | 11/18/2004SE |
| K023758 | Becker Transnasal Lacrimal (Intubation Sets)OKS · Traditional | 09/17/2003SE |
| K030054 | Disposable Vitrectomy Sets, Disposable Virectomy LensesHJK · Traditional | 02/26/2003SE |
| K992294 | Bioceramic Orbital ImplantHPZ · Traditional | 04/19/2000SE |
| K991238 | Fci Crawford Probe Intubation SetsOKS · Traditional | 07/08/1999SE |
| K980816 | Retinal Detachment Implants, Including Bands, Strips (Rails) and SpongesHQX · Traditional | 09/18/1998SE |
| K980822 | Titanium Peg SystemMQU · Traditional | 07/09/1998SE |
| K964774 | Punctum Plugs & Ready-Set Punctal PlugsLZU · Traditional | 12/20/1996SE |
Questions and answers
When was Fci Mesh Wrapped Bioceramic Orbital Implant cleared by the FDA?
Fci Mesh Wrapped Bioceramic Orbital Implant (K023400) received a 510(k) decision of Substantially Equivalent on August 22, 2003, 317 days after the submission was received.
What is the product code of K023400?
The FDA product code is HPZ – Implant, Eye Sphere, a Class II (moderate risk) device regulated under 21 CFR 886.3320.