STRIDE UNICONDYLAR KNEE
FDA 510(k) clearance K123380 · decided 2013-05-31
Clearance details
- K-number
- K123380
- Device name
- STRIDE UNICONDYLAR KNEE
- Applicant
- Blue Belt Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-01
- Decision date
- 2013-05-31
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- HSX
- Device class
- 2
- Regulation number
- 888.3520
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Blue Belt Technologies
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 |
|---|---|---|
| Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee recall (Z-1942-2014) | Blue Belt Technologies MN | 2014-06-27 |
| Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee recall (Z-1943-2014) | Blue Belt Technologies MN | 2014-06-27 |