The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus 2.0/2.3 Four Corner Fusion Plate.
| Device ID | K090983 |
| 510k Number | K090983 |
| Device Name: | APTUS 2.0/2.3 FOUR CORNER FUSION PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | MEDARTIS AG 11234 EL CAMINO REAL, STE 200 San Diego, CA 92130 |
| Contact | Kevin A Thomas |
| Correspondent | Kevin A Thomas MEDARTIS AG 11234 EL CAMINO REAL, STE 200 San Diego, CA 92130 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-07 |
| Decision Date | 2009-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630008438463 | K090983 | 000 |
| 07630008438432 | K090983 | 000 |
| 07630008402372 | K090983 | 000 |
| 07630037894230 | K090983 | 000 |
| 07630037894223 | K090983 | 000 |
| 07630037894216 | K090983 | 000 |