510(k) K990667
- Device
- KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
- Applicant
- KLS-Martin L.P.
- 510(k) number
- K990667
- Product code
- NEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-07-27
- Date received
- 1999-03-02
- 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
Related Records
Applicant Contact
- Contact
- ARTHUR J WARD
- Address
- 3234 Ella Ln. New Port Riche FL US 34655 34655
FDA Registration Numbers
- 3008812560
- 1057946
- 3015869493
- 8010177
- 1825034
- 1032347
- 9610905
- 3015399803
- 1057425
- 3008868758
- 3000270450
- 3034676720
- 2027754
- 3009417901
- 3015440604
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 |
| K031701 | OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM | Osteomed LP | 2004-07-08 |
| K002790 | ADD-ON CONDYLE | Walter Lorenz Surgical, Inc. | 2001-08-06 |
| K990637 | SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD | Synthes (Usa) | 1999-10-22 |