Product code NEI
- Device name
- Prosthesis, Condyle, Mandibular, Temporary
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.4770
- Review panel
- DE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K133285 | STRYKER TEMPORARY CONDYLAR PROSTHESIS | Stryker | 2014-04-09 |
| K081747 | MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | Synthes (Usa) | 2008-09-05 |
| K063181 | SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | Synthes (Usa) | 2007-01-05 |
| K031701 | OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM | Osteomed LP | 2004-07-08 |
| K002790 | ADD-ON CONDYLE | Walter Lorenz Surgical, Inc. | 2001-08-06 |
| K990667 | KLS-MARTIN TEMPORARY CONDYLAR IMPLANT | KLS-Martin L.P. | 2001-07-27 |
| K990637 | SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD | Synthes (Usa) | 1999-10-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327572087 | Universal Mandible AXS | Stryker Leibinger GmbH & Co. KG | 2023-09-15 |
| 37613327572088 | Universal Mandible AXS | Stryker Leibinger GmbH & Co. KG | 2023-09-15 |
| 00888118131249 | LEVEL ONE CMF | KLS-Martin L.P. | 2021-11-22 |
| 10888118131260 | LEVEL ONE CMF | KLS-Martin L.P. | 2021-11-22 |
| 00888118131256 | LEVEL ONE CMF | KLS-Martin L.P. | 2021-11-22 |
| 00888118131263 | LEVEL ONE CMF | KLS-Martin L.P. | 2021-11-22 |
| 00888118113016 | LEVEL ONE CMF | KLS-Martin L.P. | 2018-01-26 |
| 00888118073570 | LEVEL ONE CMF | KLS-Martin L.P. | 2016-03-24 |
| 00888118073471 | LEVEL ONE CMF | KLS-Martin L.P. | 2016-03-24 |
| 00888118073488 | LEVEL ONE CMF | KLS-Martin L.P. | 2016-03-24 |
| 00888118073501 | LEVEL ONE CMF | KLS-Martin L.P. | 2016-03-24 |
| 00888118073518 | LEVEL ONE CMF | KLS-Martin L.P. | 2016-03-24 |
| 00888118073532 | LEVEL ONE CMF | KLS-Martin L.P. | 2016-03-24 |
| 00841036009847 | """2.4MM"" LOCKING RECON SYSTEM" | BIOMET MICROFIXATION, INC | 2015-10-11 |
| 00841036009830 | """2.4MM"" LOCKING RECON SYSTEM" | BIOMET MICROFIXATION, INC | 2015-10-11 |
| 00841036091507 | """2.4MM"" LOCKING RECON SYSTEM" | BIOMET MICROFIXATION, INC | 2015-10-11 |
| 34546540373985 | NA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 10887587054582 | NA | Synthes GmbH | 2015-09-14 |
| 10887587054575 | NA | Synthes GmbH | 2015-09-14 |
| 10887587054568 | NA | Synthes GmbH | 2015-09-14 |
| 10887587054551 | NA | Synthes GmbH | 2015-09-14 |
| 10887587054544 | NA | Synthes GmbH | 2015-09-14 |
| 10887587054537 | NA | Synthes GmbH | 2015-09-14 |
| 10887587016443 | MatrixMANDIBLE | Synthes GmbH | 2015-09-14 |
| 10887587016436 | NA | Synthes GmbH | 2015-09-14 |
| 10887587016429 | NA | Synthes GmbH | 2015-09-14 |
| 10887587016412 | NA | Synthes GmbH | 2015-09-14 |
| 10887587016405 | NA | Synthes GmbH | 2015-09-14 |
| 10887587016399 | NA | Synthes GmbH | 2015-09-14 |
| 10887587016382 | NA | Synthes GmbH | 2015-09-14 |