The following data is part of a premarket notification filed by Impladent, Ltd. with the FDA for Tristar Bone Graft Fixation System.
| Device ID | K141764 |
| 510k Number | K141764 |
| Device Name: | TRISTAR BONE GRAFT FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | IMPLADENT, LTD. 198-45 FOOTHILL AVE. Holliswood, NY 11423 |
| Contact | Maurice Valen |
| Correspondent | Maurice Valen IMPLADENT, LTD. 198-45 FOOTHILL AVE. Holliswood, NY 11423 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-01 |
| Decision Date | 2014-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855286006242 | K141764 | 000 |
| 00083208006234 | K141764 | 000 |
| 00083208006227 | K141764 | 000 |
| 00083208006210 | K141764 | 000 |
| 00083208006203 | K141764 | 000 |
| 00083208006197 | K141764 | 000 |
| 00083208006180 | K141764 | 000 |
| 00083208006173 | K141764 | 000 |
| 00083208006142 | K141764 | 000 |
| 00083208006135 | K141764 | 000 |
| 00083208005558 | K141764 | 000 |
| 00083208006241 | K141764 | 000 |
| 00083208006418 | K141764 | 000 |
| 00855286006136 | K141764 | 000 |
| 00855286006235 | K141764 | 000 |
| 00855286006228 | K141764 | 000 |
| 00855286006211 | K141764 | 000 |
| 00855286006204 | K141764 | 000 |
| 00855286006198 | K141764 | 000 |
| 00855286006181 | K141764 | 000 |
| 00855286006174 | K141764 | 000 |
| 00855286006167 | K141764 | 000 |
| 00855286006150 | K141764 | 000 |
| 00855286006143 | K141764 | 000 |
| 00083208000003 | K141764 | 000 |