The following data is part of a premarket notification filed by The Straumann Co. with the FDA for Modus Sagittal Split Plate.
| Device ID | K993862 |
| 510k Number | K993862 |
| Device Name: | MODUS SAGITTAL SPLIT PLATE |
| Classification | Plate, Bone |
| Applicant | THE STRAUMANN CO. RESERVOIR PL. 1601 TRAPELO RD. Waltham, MA 02451 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert THE STRAUMANN CO. RESERVOIR PL. 1601 TRAPELO RD. Waltham, MA 02451 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-15 |
| Decision Date | 1999-12-29 |
| Summary: | summary |