The following data is part of a premarket notification filed by Tita-link with the FDA for Bollard Miniplate Skeletal Anchorage System.
| Device ID | K091051 |
| 510k Number | K091051 |
| Device Name: | BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | TITA-LINK 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Joseph Azary |
| Correspondent | Joseph Azary TITA-LINK 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-13 |
| Decision Date | 2009-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05430000515122 | K091051 | 000 |
| 05430000515023 | K091051 | 000 |
| 05430000515030 | K091051 | 000 |
| 05430000515047 | K091051 | 000 |
| 05430000515054 | K091051 | 000 |
| 05430000515061 | K091051 | 000 |
| 05430000515078 | K091051 | 000 |
| 05430000515085 | K091051 | 000 |
| 05430000515092 | K091051 | 000 |
| 05430000515108 | K091051 | 000 |
| 05430000515115 | K091051 | 000 |
| 05430000515016 | K091051 | 000 |