OsteoFab Patient Specific Facial Device
FDA 510(k) K161052 · Oxford Performance Materials, Inc.
510(k) numberK161052
Submission
- Device name
- OsteoFab Patient Specific Facial Device
- Applicant
- Oxford Performance Materials, Inc.
South Windsor, CT, US - Received
- April 14, 2016
- Decision date
- July 20, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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| K211514 | Longeviti PorousFit implantKKY · Traditional | Longeviti Neuro Solutions, LLC | 07/15/2021SE |
| 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 |
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| 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 |
|---|---|---|
| K190915 | OsteoFab Suture AnchorsMBI · Traditional | 07/03/2019SE |
| K180064 | OsteoFab Patient Specific Cranial DeviceGXN · Traditional | 07/27/2018SE |
| K142005 | SpineFab Vertebral Body Replacement (VBR) SystemMQP · Traditional | 07/10/2015SE |
| K133809 | Osteofab Patient Specific Facial DeviceKKY · Traditional | 07/28/2014SE |
| K121818 | Osteofab Patient Specific Cranial DeviceGXN · Traditional | 02/07/2013SE |
Questions and answers
When was OsteoFab Patient Specific Facial Device cleared by the FDA?
OsteoFab Patient Specific Facial Device (K161052) received a 510(k) decision of Substantially Equivalent on July 20, 2016, 97 days after the submission was received.
What is the product code of K161052?
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.