The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus Ulna Shortening 2.5.
| Device ID | K141232 |
| 510k Number | K141232 |
| Device Name: | APTUS ULNA SHORTENING 2.5 |
| Classification | Plate, Fixation, Bone |
| Applicant | MEDARTIS AG 12264 EL CAMINO REAL, STE 400 San Diego, CA 92130 |
| Contact | Kevin A Thomas |
| Correspondent | Kevin A Thomas MEDARTIS AG 12264 EL CAMINO REAL, STE 400 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 | 2014-05-13 |
| Decision Date | 2014-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630008476489 | K141232 | 000 |
| 07630008471170 | K141232 | 000 |
| 07630008470937 | K141232 | 000 |
| 07630008470845 | K141232 | 000 |
| 07630008470814 | K141232 | 000 |
| 07630008470784 | K141232 | 000 |
| 07630008470753 | K141232 | 000 |
| 07630008470722 | K141232 | 000 |
| 07630008470692 | K141232 | 000 |
| 07630008470661 | K141232 | 000 |
| 07630008470630 | K141232 | 000 |
| 07630008470609 | K141232 | 000 |
| 07630008470579 | K141232 | 000 |
| 07630008471200 | K141232 | 000 |
| 07630008471231 | K141232 | 000 |
| 07630008476458 | K141232 | 000 |
| 07630008476427 | K141232 | 000 |
| 07630008476397 | K141232 | 000 |
| 07630008476366 | K141232 | 000 |
| 07630008476335 | K141232 | 000 |
| 07630008476304 | K141232 | 000 |
| 07630008476274 | K141232 | 000 |
| 07630008476243 | K141232 | 000 |
| 07630008476212 | K141232 | 000 |
| 07630008476182 | K141232 | 000 |
| 07630008476151 | K141232 | 000 |
| 07630008476120 | K141232 | 000 |
| 07630037894865 | K141232 | 000 |