DeviceClearance

SWANSON TITANIUM GREAT TOE IMPLANT— 510(k) K864492

Substantially Equivalent

Dow Corning Wright

FDA 510(k) clearance K864492 for SWANSON TITANIUM GREAT TOE IMPLANT, Substantially Equivalent on 1987-04-15. Applicant: Dow Corning Wright. Device class: 2.

Clearance details

Applicant
Dow Corning Wright
Product code
Code KWD
Device class
Class 2
Regulation
21 CFR 888.3730
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Arlington, TN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KWD

product code KWD
Injury
164
Total
164

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K864492

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K864492.

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