HXA
- Product code
- HXA
- Device name
- Prosthesis, Tendon, Passive
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3025
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 11
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243477 | 2025-01-10 | Askorn Medical | Universal Tendon Spacer |
Official FDA classification page: HXA
Classification and pathway per current FDA publications. Data from openFDA (CC0).