K992106 is an FDA 510(k) clearance for the MODUS SYSTEM SELF-DRILLING SCREWS. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Medartis AG (Waltham, US). The FDA issued a Cleared decision on September 17, 1999, 87 days after receiving the submission on June 22, 1999.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K992106 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 1999 |
| Decision Date | September 17, 1999 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |