The following data is part of a premarket notification filed by Medartis Ag with the FDA for Modus System Self-drilling Screws.
| Device ID | K992106 |
| 510k Number | K992106 |
| Device Name: | MODUS SYSTEM SELF-DRILLING SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | MEDARTIS AG 1601 TRAPELO RD. RESERVOIR PLACE Waltham, MA 02451 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert MEDARTIS AG 1601 TRAPELO RD. RESERVOIR PLACE Waltham, MA 02451 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-22 |
| Decision Date | 1999-09-17 |
| Summary: | summary |