APTUS ULNA SHORTENING 2.5
FDA 510(k) clearance K141232 · decided 2014-06-23
Clearance details
- K-number
- K141232
- Device name
- APTUS ULNA SHORTENING 2.5
- Applicant
- Medartis AG
- Decision
- Substantially Equivalent
- Date received
- 2014-05-13
- Decision date
- 2014-06-23
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medartis AG
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated fo recall (Z-0150-2015) | Medartis, Inc. | 2014-10-30 |