Silimed Chin Implants
FDA 510(k) K981850 · Silimed, LLC
510(k) numberK981850
Submission
- Device name
- Silimed Chin Implants
- Applicant
- Silimed, LLC
Crofton, MD, US - Received
- May 26, 1998
- Decision date
- July 9, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
| K254233 | MEDPOR Customized Implant KitFWP · Special | Stryker Leibinger GmbH & Co KG | 03/12/2026SE |
| 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 |
|---|---|---|
| K042054 | Silimed Pectoral ImplantMIB · Traditional | 02/23/2005SE |
| K981852 | Silimed Tissue ExpanderLCJ · Traditional | 08/05/1998SE |
| K974479 | Silimed Vaginal StentKXP · Traditional | 08/05/1998SE |
| K981851 | Silimed Silicone Carving BlockMIB · Traditional | 07/09/1998SE |
| K981835 | Silimed Malar ImplantLZK · Traditional | 07/09/1998SE |
| K981833 | Silimed Nasal L Shaped ImplantFZE · Traditional | 06/26/1998SE |
| K980221 | Silimed Nasal RetainerLYA · Traditional | 04/02/1998SE |
| K974482 | Silimed Gluteal ImplantMIB · Traditional | 02/24/1998SE |
| K974480 | Silimed Calf ImplantMIB · Traditional | 02/24/1998SE |
Questions and answers
When was Silimed Chin Implants cleared by the FDA?
Silimed Chin Implants (K981850) received a 510(k) decision of Substantially Equivalent on July 9, 1998, 44 days after the submission was received.
What is the product code of K981850?
The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.