SWANSON TITANIUM TRAPEZIUM IMPLANT— 510(k) K864489

Name: FDA 510(k) clearance K864489
Creator: U.S. Food and Drug Administration
Published: 1987-04-15

Substantially Equivalent

Dow Corning Wright

FDA 510(k) clearance K864489 for SWANSON TITANIUM TRAPEZIUM IMPLANT, Substantially Equivalent on 1987-04-15. Applicant: Dow Corning Wright. Device class: 2.

Clearance details

Applicant: Dow Corning Wright
Product code: Code KYI
Device class: Class 2
Regulation: 21 CFR 888.3770
Advisory panel: Orthopedic
Date received: 1986-11-13
Decision date: 1987-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K864489

K-number listed on FDA's recall record

Z-0572-2020 — SWANSON TRAPEZIUM IMPLANT, Part Number 4520002Class II·Terminated·Wright Medical Technology, Inc.·20161108

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K864489.

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