The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus Proximal Humerus System.
| Device ID | K120108 |
| 510k Number | K120108 |
| Device Name: | APTUS PROXIMAL HUMERUS SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | MEDARTIS AG 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | Kevin A Thomas |
| Correspondent | Kevin A Thomas MEDARTIS AG 11234 EL CAMINO REAL SUITE 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 | 2012-01-13 |
| Decision Date | 2012-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630008475642 | K120108 | 000 |
| 07630037896210 | K120108 | 000 |
| 07630037896142 | K120108 | 000 |
| 07630037896135 | K120108 | 000 |
| 07630037896128 | K120108 | 000 |
| 07630037896111 | K120108 | 000 |
| 07630037896098 | K120108 | 000 |
| 07630037886815 | K120108 | 000 |
| 07630037886792 | K120108 | 000 |
| 07630037886754 | K120108 | 000 |
| 07630037896227 | K120108 | 000 |
| 07630008456009 | K120108 | 000 |
| 07630008475611 | K120108 | 000 |
| 07630008456733 | K120108 | 000 |
| 07630008456702 | K120108 | 000 |
| 07630008456672 | K120108 | 000 |
| 07630008456450 | K120108 | 000 |
| 07630008456429 | K120108 | 000 |
| 07630008456399 | K120108 | 000 |
| 07630008456245 | K120108 | 000 |
| 07630008456030 | K120108 | 000 |
| 07630037886730 | K120108 | 000 |