The following data is part of a premarket notification filed by Synthes with the FDA for Synthes Uss (10.0mm Side Opening Screws).
| Device ID | K003061 |
| 510k Number | K003061 |
| Device Name: | SYNTHES USS (10.0MM SIDE OPENING SCREWS) |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SYNTHES 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Contact | Jonathan Gilbert |
| Correspondent | Jonathan Gilbert SYNTHES 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Product Code | KWQ |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-02 |
| Decision Date | 2000-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034821306 | K003061 | 000 |
| 10705034821160 | K003061 | 000 |
| 10705034821177 | K003061 | 000 |
| 10705034821184 | K003061 | 000 |
| 10705034821191 | K003061 | 000 |
| 10705034821207 | K003061 | 000 |
| 10705034821221 | K003061 | 000 |
| 10705034821245 | K003061 | 000 |
| 10705034821269 | K003061 | 000 |
| 10705034821283 | K003061 | 000 |
| 10705034821153 | K003061 | 000 |