Prosthesis, Condyle, Mandibular, Temporary
FDA product code NEI · Class II (moderate risk) · 21 CFR 872.4770 · Dental
7510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K133285 | Stryker Temporary Condylar ProsthesisNEI · Traditional | Stryker | 04/09/2014SE |
| K081747 | Modification to Synthes (USA) Condylar Head Add-On SystemNEI · Traditional | Synthes (Usa) | 09/05/2008SE |
| K063181 | Synthes (USA) Condylar Head Add-On SystemNEI · Traditional | Synthes (Usa) | 01/05/2007SE |
| K031701 | Osteomed Temporary Condylar Attachment SystemNEI · Traditional | Osteomed LP | 07/08/2004SE |
| K002790 | Add-On CondyleNEI · Traditional | Walter Lorenz Surgical, Inc. | 08/06/2001SE |
| K990667 | Kls-Martin Temporary Condylar ImplantNEI · Traditional | KLS-Martin L.P. | 07/27/2001SE |
| K990637 | Synthes Locking Reconstruction Plate (LRP) with Condylar HeadNEI · Traditional | Synthes (Usa) | 10/22/1999SE |