SINGLE SIZE TENDON SPACER— 510(k) K000019

Substantially Equivalent

Medist International

FDA 510(k) clearance K000019 for SINGLE SIZE TENDON SPACER, Substantially Equivalent on 2000-03-29. Applicant: Medist International. Device class: 2.

Clearance details

Applicant: Medist International
Product code: Code HXA
Device class: Class 2
Regulation: 21 CFR 888.3025
Advisory panel: Orthopedic
Date received: 2000-01-04
Decision date: 2000-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakeland, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HXA

K243477 — Universal Tendon Spacer2025-01-10
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.