The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Kls-martin Ortho Anchorage System.
| Device ID | K033483 |
| 510k Number | K033483 |
| Device Name: | KLS-MARTIN ORTHO ANCHORAGE SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville, FL 32246 |
| Contact | Jennifer Damato |
| Correspondent | Jennifer Damato KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville, FL 32246 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-04 |
| Decision Date | 2004-01-15 |
| Summary: | summary |