STRIDE UNICONDYLAR KNEE— 510(k) K123380
Substantially EquivalentBlue Belt Technologies, Inc.
FDA 510(k) clearance K123380 for STRIDE UNICONDYLAR KNEE, Substantially Equivalent on 2013-05-31. Applicant: Blue Belt Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Blue Belt Technologies, Inc.
- Product code
- Code HSX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3520
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pittsburgh, PA, US
Recent devices under product code HSX
view allMore clearances from Blue Belt Technologies, Inc.
view allAdverse events under product code HSX
product code HSX- Injury
- 1,003
- Other
- 1
- Total
- 1,004
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K123380
K-number listed on FDA's recall record- Z-1942-2014 — Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.
- Z-1943-2014 — Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123380.
Data sourced from openFDA. This site is unofficial and independent of the FDA.