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 |