Anadias Zara System Malar Implants
FDA 510(k) K871190 · Anadias, Inc.
510(k) numberK871190
Submission
- Device name
- Anadias Zara System Malar Implants
- Applicant
- Anadias, Inc.
Belleville, NJ, US - Received
- March 24, 1987
- Decision date
- April 10, 1987
- 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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| 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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| K854192 | Anadias Nasal Saw BladesGFA · Traditional | 11/13/1985SE |
Questions and answers
When was Anadias Zara System Malar Implants cleared by the FDA?
Anadias Zara System Malar Implants (K871190) received a 510(k) decision of Substantially Equivalent on April 10, 1987, 17 days after the submission was received.
What is the product code of K871190?
The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.