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HXA

Prosthesis, Tendon, Passive

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)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
11 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-01-10.

NumberDecision dateApplicantDevice nameSummary
K2434772025-01-10Askorn MedicalUniversal Tendon SpacerPDF

1 summaries are archived here for direct download.

Official FDA classification page: HXA
Classification and pathway per current FDA publications. Data from openFDA (CC0).