Universal Tendon Spacer— 510(k) K243477

Substantially Equivalent

Askorn Medical

FDA 510(k) clearance K243477 for Universal Tendon Spacer, Substantially Equivalent on 2025-01-10. Applicant: Askorn Medical. Device class: 2.

Clearance details

Applicant: Askorn Medical
Product code: Code HXA
Device class: Class 2
Regulation: 21 CFR 888.3025
Advisory panel: Orthopedic
Date received: 2024-11-08
Decision date: 2025-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cesson-Sévigné, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code HXA

K000019 — SINGLE SIZE TENDON SPACER2000-03-29
K973385 — OVAL SHAPES1997-12-05
K964359 — AVANTA ORTHOPAEDICS TENDON SPACER1997-03-25
K930125 — PHOENIX BONE SCREWS PBS-TYPE SERIES1993-12-30
K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC1987-09-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.