Spivey-Allen Orbital Floor Implant
FDA 510(k) K900930 · Oculo Plastik, Inc.
510(k) numberK900930
Submission
- Device name
- Spivey-Allen Orbital Floor Implant
- Applicant
- Oculo Plastik, Inc.
Montreal, Quebec Canada, CA - Received
- February 27, 1990
- Decision date
- May 15, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQX – Implant, Orbital, Extra-Ocular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3340
- Specialty
- Ophthalmic
- Implant
- Yes
Other 510(k)s with product code HQX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023481 | Microvision Scleral Buckling ComponentsHQX · Traditional | Microvision, Inc. | 01/08/2003SE |
| K983581 | Ocu-Guard and Ocu-Guard SuppleHQX · Special | Bio-Vascular, Inc. | 11/06/1998SE |
| K980816 | Retinal Detachment Implants, Including Bands, Strips (Rails) and SpongesHQX · Traditional | Fci Ophthalmics, Inc. | 09/18/1998SE |
| K963219 | Retinal Detachment Implants; Including Bans, Strips, Tires, Sleeves, Cords and SpongesHQX · Traditional | Fci Ophthalmics, Inc. | 10/28/1996SE |
| K950806 | Solid Dilicone Implants, Sdilicone Sponge ImplantsHQX · Traditional | Mira, Inc. | 06/05/1996SE |
| K950599 | Stors Scleral Sponge II (Lincoff Design)HQX · Traditional | Storz Ophthalmics, Inc. | 03/02/1995SE |
| K945172 | Visitec Silicone Retinal Implants/ExplantsHQX · Traditional | Visitec Co. | 01/17/1995SE |
| K902308 | Tamcenan Ocular Explants and BandsHQX · Traditional | Tamcenan Corp. | 06/19/1990SE |
| K901002 | O'Donnell, Socket Reconstruction ProsthesesHQX · Traditional | Oculo Plastik, Inc. | 05/22/1990SE |
| K900929 | Putterman-Scott, Socket Reconstruction BilateralHQX · Traditional | Oculo Plastik, Inc. | 05/18/1990SE |
More from Oculo Plastik, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K123764 | Durette Ocular ImplantHPZ · Traditional | 01/31/2013SE |
| K112176 | Silicone SpheresHPZ · Special | 09/15/2011SE |
| 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 |
| K900928 | Cox Malar Eminence ImplantsHQX · Traditional | 05/15/1990SE |
| K900927 | Codere-Durette Orbital Floor ImplantHQX · Traditional | 05/15/1990SE |
Questions and answers
When was Spivey-Allen Orbital Floor Implant cleared by the FDA?
Spivey-Allen Orbital Floor Implant (K900930) received a 510(k) decision of Substantially Equivalent on May 15, 1990, 77 days after the submission was received.
What is the product code of K900930?
The FDA product code is HQX – Implant, Orbital, Extra-Ocular, a Class II (moderate risk) device regulated under 21 CFR 886.3340.