Flowers Jowl Implant
FDA 510(k) K905268 · Implantech Associates, Inc.
510(k) numberK905268
Submission
- Device name
- Flowers Jowl Implant
- Applicant
- Implantech Associates, Inc.
Washington, DC, US - Received
- November 21, 1990
- Decision date
- January 31, 1991
- 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
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 |
| 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 |
|---|---|---|
| K200610 | Customized Contour ImplantFWP · Traditional | 12/23/2020SE |
| K191130 | Customized Contour ImplantFWP · Traditional | 08/23/2019SE |
| K172389 | ePTFE-Coated Auricular ImplantFZD · Traditional | 07/18/2018SE |
| K141027 | 3D Eptfe; Anatomical Chin, Curvilinear Chin, Extended Anatomical Chin Implant, Submalar…FWP · Traditional | 07/10/2014SE |
| K071470 | Implantech Eptfe Sheeting, Model Eptfe-XxxFTL · Traditional | 08/31/2007SE |
| K052505 | Calf Implant, Model EC17-XMIB · Traditional | 11/04/2005SE |
| K052504 | Gluteal Implant, Models RND 5-X, TRD 6-XMIB · Traditional | 11/04/2005SE |
| K013732 | GelzoneMDA · Traditional | 02/07/2002SE |
| K012419 | Conform Sheeting, Model IgelMDA · Traditional | 10/24/2001SE |
| K002886 | Implantech Composite Facial Implants (Malar, Chin, and Nasal)LZK · Traditional | 11/24/2000SE |
Questions and answers
When was Flowers Jowl Implant cleared by the FDA?
Flowers Jowl Implant (K905268) received a 510(k) decision of Substantially Equivalent on January 31, 1991, 71 days after the submission was received.
What is the product code of K905268?
The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.