The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus 2.0 Radial Head System.
| Device ID | K090053 |
| 510k Number | K090053 |
| Device Name: | APTUS 2.0 RADIAL HEAD SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | MEDARTIS AG 11234 EL CAMINO REAL, STE 200 San Diego, CA 92130 |
| Contact | Kevin Thomas |
| Correspondent | Kevin 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 | 2009-01-08 |
| Decision Date | 2009-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630008404475 | K090053 | 000 |
| 07630008402358 | K090053 | 000 |
| 07630037801214 | K090053 | 000 |
| 07630894800290 | K090053 | 000 |
| 07630037801252 | K090053 | 000 |
| 07630037801245 | K090053 | 000 |
| 07630894800252 | K090053 | 000 |
| 07630037801238 | K090053 | 000 |
| 07630894800238 | K090053 | 000 |
| 07630037801221 | K090053 | 000 |
| 07630894800214 | K090053 | 000 |
| 07630037800521 | K090053 | 000 |
| 07630037899914 | K090053 | 000 |
| 07630037800538 | K090053 | 000 |
| 07630037800545 | K090053 | 000 |
| 07630008402365 | K090053 | 000 |
| 07630008404086 | K090053 | 000 |
| 07630008404468 | K090053 | 000 |
| 07630008404451 | K090053 | 000 |
| 07630008404444 | K090053 | 000 |
| 07630008404437 | K090053 | 000 |
| 07630008404420 | K090053 | 000 |
| 07630008404413 | K090053 | 000 |
| 07630008404406 | K090053 | 000 |
| 07630008404390 | K090053 | 000 |
| 07630008404383 | K090053 | 000 |
| 07630008404130 | K090053 | 000 |
| 07630008404123 | K090053 | 000 |
| 07630008404116 | K090053 | 000 |
| 07630008404109 | K090053 | 000 |
| 07630008404093 | K090053 | 000 |
| 07630037894179 | K090053 | 000 |