Chin Implant Style I
FDA 510(k) K945998 · King & Spalding
510(k) numberK945998
Submission
- Device name
- Chin Implant Style I
- Applicant
- King & Spalding
Washington, DC, US - Received
- November 30, 1994
- Decision date
- February 7, 1995
- 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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| 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 |
|---|---|---|
| K942423 | Nais Wrist Blood Pressure MeterDXN · Traditional | 02/15/1995SE |
| K942422 | Panasonic Wrist Blood Pressure MeterDXN · Traditional | 02/15/1995SE |
| K944408 | Implantech Medical Grade Silicone SheetingMIB · Traditional | 11/09/1994SE |
| K942421 | Implantech Lateral Mandibular Bar ImplantLZK · Traditional | 08/08/1994SE |
| K942420 | Implantech Midface-Submalar Le Fort ImplantLZK · Traditional | 08/08/1994SE |
| K941972 | Hemo-O-LokFZP · Traditional | 06/29/1994SE |
Questions and answers
When was Chin Implant Style I cleared by the FDA?
Chin Implant Style I (K945998) received a 510(k) decision of Substantially Equivalent on February 7, 1995, 69 days after the submission was received.
What is the product code of K945998?
The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.