The following data is part of a premarket notification filed by Smith & Nephew Dyonics, Inc. with the FDA for Dyonics Fixation Screws.
| Device ID | K945182 |
| 510k Number | K945182 |
| Device Name: | DYONICS FIXATION SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Elizabeth A Ryan |
| Correspondent | Elizabeth A Ryan SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-24 |
| Decision Date | 1995-01-24 |