510(k) K031701
- Device
- OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM
- Applicant
- Osteomed LP
- 510(k) number
- K031701
- Product code
- NEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-07-08
- Date received
- 2003-06-02
- Regulation
- 872.4770
- Classification name
- Prosthesis, Condyle, Mandibular, Temporary
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAWN T HOLDEMAN
- Address
- 3885 Arapaho Rd. Addison TX US 75001 75001
FDA Registration Numbers#
- 3015440604
- 3000270450
- 8010177
- 3015399803
- 3015869493
- 9610905
- 3008868758
- 1057425
- 2027754
- 1032347
- 1825034
- 1057946
- 3034676720
- 3009417901
- 3008812560
Source Documents#
Other 510(k) Records For Product Code NEI#
| 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 |
| 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 |