Zara Chin Implant
FDA 510(k) K910456 · Byron Medical
510(k) numberK910456
Submission
- Device name
- Zara Chin Implant
- Applicant
- Byron Medical
Tucson, AZ, US - Received
- February 4, 1991
- Decision date
- February 19, 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
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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 |
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| K981172 | Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and NeedlesQPB · Traditional | 06/30/1998SE |
| K980738 | Psi-Tec Syringe Infusion Pump and Accessories for General Fluid Irrigaion/InfiltrationFRN · Traditional | 06/16/1998SE |
| K980392 | Psi-Tec AspiratorBTA · Traditional | 03/05/1998SE |
| K974295 | Byron Medical Aspiration and Infiltration/Irrigation TubingKGZ · Traditional | 02/10/1998SE |
| K973133 | Big Bag 3000 Pressure InfusorFRN · Traditional | 09/12/1997ST |
| K934179 | Disposable Bag DecanterKPE · Traditional | 05/23/1994SE |
| K934233 | Zara Zone IV Malar Implant ModificationLZK · Traditional | 02/03/1994SE |
Questions and answers
When was Zara Chin Implant cleared by the FDA?
Zara Chin Implant (K910456) received a 510(k) decision of Substantially Equivalent on February 19, 1991, 15 days after the submission was received.
What is the product code of K910456?
The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.