Longeviti PorousFit implant
FDA 510(k) K211514 · Longeviti Neuro Solutions, LLC
510(k) numberK211514
Submission
- Device name
- Longeviti PorousFit implant
- Applicant
- Longeviti Neuro Solutions, LLC
Hunt Valley, MD, US - Received
- May 17, 2021
- Decision date
- July 15, 2021
- 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 |
|---|---|---|---|
| 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 |
| K133046 | Omnipore Customized Surgical ImplantsKKY · Traditional | Matrix Surgical Holdings, LLC/Matrix Surgical USA | 05/14/2014SE |
| 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 |
|---|---|---|
| K260709 | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring…GXN · Traditional | 06/25/2026SE |
| K231920 | Longeviti ClearFit OTS Cranial ImplantGXN · Special | 11/09/2023SE |
| K212058 | Longeviti ClearFit OTS Cranial ImplantsGXN · Traditional | 09/08/2021SE |
| K210616 | Longeviti PMMA Static Cranial ImplantGXN · Special | 03/31/2021SE |
| K203349 | Longeviti ClearFit Cranial ImplantGXN · Special | 12/16/2020SE |
| K202901 | Longeviti ClearFit Cranial ImplantGXN · Special | 10/30/2020SE |
| K191210 | Longeviti ClearFit Cranial ImplantGXN · Traditional | 01/09/2020SE |
| K170410 | Longeviti PMMA Static Cranial ImplantGXN · Traditional | 03/23/2018SE |
Questions and answers
When was Longeviti PorousFit implant cleared by the FDA?
Longeviti PorousFit implant (K211514) received a 510(k) decision of Substantially Equivalent on July 15, 2021, 59 days after the submission was received.
What is the product code of K211514?
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.