Cui Curvilinear Silicone Chin
FDA 510(k) K904349 · Cui Corp.
510(k) numberK904349
Submission
- Device name
- Cui Curvilinear Silicone Chin
- Applicant
- Cui Corp.
Santa Barbara, CA, US - Received
- September 24, 1990
- Decision date
- November 26, 1990
- 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 |
|---|---|---|
| K913140 | Silicone Gel SheetingMDA · Traditional | 09/30/1991SE |
| K904350 | Cui Dorsal Columella ProsthesisFZE · Traditional | 11/26/1990SE |
| K904348 | Cui Feathered Silicone MalarLZK · Traditional | 11/26/1990SE |
| K903329 | Cui Anatomical Silicone MalarLZK · Traditional | 09/10/1990SE |
| K903328 | Cui Premaxillary ImplantFZE · Traditional | 09/10/1990SE |
| K903327 | Cui Articulated Silicone ChinFWP · Traditional | 09/10/1990SE |
Questions and answers
When was Cui Curvilinear Silicone Chin cleared by the FDA?
Cui Curvilinear Silicone Chin (K904349) received a 510(k) decision of Substantially Equivalent on November 26, 1990, 63 days after the submission was received.
What is the product code of K904349?
The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.