The following data is part of a premarket notification filed by Synthes with the FDA for Uss-line Extension.
| Device ID | K010108 |
| 510k Number | K010108 |
| Device Name: | USS-LINE EXTENSION |
| Classification | Orthosis, Spinal Pedicle Fixation |
| 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 | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-12 |
| Decision Date | 2001-06-06 |