Porex(Tm) Prosthesis, Chin, Internal
FDA 510(k) K863941 · Porex Medical
510(k) numberK863941
Submission
- Device name
- Porex(Tm) Prosthesis, Chin, Internal
- Applicant
- Porex Medical
Fairburn, GA, US - Received
- October 10, 1986
- Decision date
- October 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FWP – Prosthesis, Chin, Internal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3550
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K232593 | FITme Customized Silicone ImplantFWP · Traditional | Keosan Trading Co. | 11/22/2023SE |
| K200610 | Customized Contour ImplantFWP · Traditional | Implantech Associates, Inc. | 12/23/2020SE |
| K191130 | Customized Contour ImplantFWP · Traditional | Implantech Associates, Inc. | 08/23/2019SE |
| K191916 | Stryker CMF MEDPOR Priority Customized Implant KitFWP · Special | Stryker Leibinger GmbH & Co KG | 08/15/2019SE |
| K153508 | Stryker CMF MEDPOR Customized ImplantFWP · Traditional | Stryker | 02/05/2016SE |
| K152463 | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantFWP · Traditional | Poriferous, LLC | 01/20/2016SE |
| K143173 | Stryker CMF MEDPOR Customized ImplantFWP · Traditional | Stryker | 03/23/2015SE |
| K141027 | 3D Eptfe; Anatomical Chin, Curvilinear Chin, Extended Anatomical Chin Implant, Submalar…FWP · Traditional | Implantech Associates, Inc. | 07/10/2014SE |
| K121315 | Stryker CMF Medpor Customized ImplantFWP · Traditional | Howmedica Osteonics Corp. | 11/01/2012SE |
More from Howmedica Osteonics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K872791 | Porex Nerve LocatorETN · Traditional | 10/20/1987SE |
| K873044 | Porex Otology InstrumentsLRC · Traditional | 09/04/1987SE |
| K872947 | Porex Quality Plastic Surgery InstrumentsKDG · Traditional | 08/21/1987SE |
| K863946 | Porex(Tm) Extra-Ocular Orbital ImplantHQX · Traditional | 02/27/1987SE |
| K863943 | Porex(Tm) Eye Sphere ImplantHPZ · Traditional | 02/27/1987SE |
| K870257 | Porex(Tm) Silicone Surgical Implants for E.N.T. · Traditional | 02/24/1987SE |
| K870182 | Porex(Tm) Malar Implant · Traditional | 02/24/1987SE |
| K870154 | Porex(Tm) Tissue ExpanderLCJ · Traditional | 02/24/1987SE |
| K863942 | Porex(Tm) Nose ProsthesisFZE · Traditional | 10/24/1986SE |
| K863939 | Porex(Tm) Ear ProsthesisFZD · Traditional | 10/24/1986SE |
Questions and answers
When was Porex(Tm) Prosthesis, Chin, Internal cleared by the FDA?
Porex(Tm) Prosthesis, Chin, Internal (K863941) received a 510(k) decision of Substantially Equivalent on October 24, 1986, 14 days after the submission was received.
What is the product code of K863941?
The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.