510(k) K063181
- Device
- SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
- Applicant
- SYNTHES (USA)
- 510(k) number
- K063181
- Product code
- NEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-01-05
- Date received
- 2006-10-19
- 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
- DEBORAH L JACKSON
- Address
- 1301 Goshen Pkwy. West Chester PA US 19380 19380
FDA Registration Numbers#
- 1032347
- 3000270450
- 3009417901
- 3015440604
- 8010177
- 3015399803
- 1057946
- 1825034
- 3008812560
- 3015869493
- 2027754
- 3034676720
- 9610905
- 1057425
- 3008868758
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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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