T2 TIBIAL NAILING SYSTEM
FDA 510(k) clearance K131365 · decided 2013-10-10
Clearance details
- K-number
- K131365
- Device name
- T2 TIBIAL NAILING SYSTEM
- Applicant
- Stryker Trauma AG
- Decision
- Substantially Equivalent
- Date received
- 2013-05-13
- Decision date
- 2013-10-10
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mahwah, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Stryker Trauma 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 |
|---|---|---|
| Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary recall (Z-0882-2016) | Stryker Howmedica Osteonics Corp. | 2016-02-25 |
| Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08 recall (Z-0065-2015) | Stryker Howmedica Osteonics Corp. | 2014-10-14 |