The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Dual-opening Uss.
| Device ID | K020517 |
| 510k Number | K020517 |
| Device Name: | SYNTHES DUAL-OPENING USS |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Vikki M Hoffman |
| Correspondent | Vikki M Hoffman SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-19 |
| Decision Date | 2002-04-15 |
| Summary: | summary |