Omnipore Customized Surgical Implants
FDA 510(k) K133046 · Matrix Surgical Holdings, LLC/Matrix Surgical USA
510(k) numberK133046
Submission
- Device name
- Omnipore Customized Surgical Implants
- Applicant
- Matrix Surgical Holdings, LLC/Matrix Surgical USA
Alpharetta, GA, US - Received
- September 27, 2013
- Decision date
- May 14, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KKY – Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3500
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code KKY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K211514 | Longeviti PorousFit implantKKY · Traditional | Longeviti Neuro Solutions, LLC | 07/15/2021SE |
| K161052 | OsteoFab Patient Specific Facial DeviceKKY · Special | Oxford Performance Materials, Inc. | 07/20/2016SE |
| K160988 | Biopor, AOC Porous Polyethylene, CereporKKY · Traditional | Ceremed , Inc. | 07/14/2016SE |
| K141880 | Biopor Aoc Porous Polyethylene, CereporKKY · Traditional | Ceremed , Inc. | 04/16/2015SE |
| K133809 | Osteofab Patient Specific Facial DeviceKKY · Traditional | Oxford Performance Materials | 07/28/2014SE |
| K140437 | Su-Por Surgical ImplantKKY · Traditional | Poriferous, LLC | 06/13/2014SE |
| K123908 | Omnipore Surgical Implants and AccessoriesKKY · Traditional | Matrix Surgical USA | 07/31/2013SE |
| K111323 | Synthes Synpor HD Porous Polyethylene Threr Dimensional ImplantsKKY · Traditional | Synthes, Inc. | 11/16/2011SE |
| K103010 | Stryker Patient Specific Polymer ImplantKKY · Special | Howmedica Osteonics Corp., Dba Stryker… | 10/26/2010SE |
| K080507 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical ImplantKKY · Traditional | Ceremed , Inc. | 04/21/2008SE |
More from Ceremed , Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K180249 | OmniPore DUROMAX Surgical ImplantsJEY · Traditional | 10/11/2018SE |
Questions and answers
When was Omnipore Customized Surgical Implants cleared by the FDA?
Omnipore Customized Surgical Implants (K133046) received a 510(k) decision of Substantially Equivalent on May 14, 2014, 229 days after the submission was received.
What is the product code of K133046?
The FDA product code is KKY – Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction, a Class II (moderate risk) device regulated under 21 CFR 878.3500.