FITme Customized Silicone Implant
FDA 510(k) K232593 · Keosan Trading Co.
510(k) numberK232593
Submission
- Device name
- FITme Customized Silicone Implant
- Applicant
- Keosan Trading Co.
Seoul, KR - Received
- August 25, 2023
- Decision date
- November 22, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
Other 510(k)s with product code FWP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254233 | MEDPOR Customized Implant KitFWP · Special | Stryker Leibinger GmbH & Co KG | 03/12/2026SE |
| 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 |
| K091011 | Pureform Eptfe Facial Implants (Nasal, Chin, Maler)FWP · Traditional | Surgical Technology Laboratories, Inc ("Stl") | 04/22/2009SE |
More from Surgical Technology Laboratories, Inc ("Stl")
| 510(k) | Device | Decision |
|---|---|---|
| K241150 | MISTI Silicone ImplantMIB · Traditional | 07/24/2024SE |
Questions and answers
When was FITme Customized Silicone Implant cleared by the FDA?
FITme Customized Silicone Implant (K232593) received a 510(k) decision of Substantially Equivalent on November 22, 2023, 89 days after the submission was received.
What is the product code of K232593?
The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.