The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Click'x Monoaxial Screws And Hooks.
| Device ID | K031175 |
| 510k Number | K031175 |
| Device Name: | CLICK'X MONOAXIAL SCREWS AND HOOKS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | John Walsh |
| Correspondent | John Walsh SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-14 |
| Decision Date | 2003-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981SD046000180 | K031175 | 000 |
| H981SD046000160 | K031175 | 000 |
| H981SD046000140 | K031175 | 000 |