DeviceClearance

TRINITY ACETABULAR SYSTEM— 510(k) K093472

Substantially Equivalent

Corin USA

FDA 510(k) clearance K093472 for TRINITY ACETABULAR SYSTEM, Substantially Equivalent on 2010-11-23. Applicant: Corin USA. Device class: 2.

Clearance details

Applicant
Corin USA
Product code
Code MEH
Device class
Class 2
Regulation
21 CFR 888.3353
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tampa, FL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MEH

product code MEH
Injury
2,021
Total
2,021

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 K093472

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 K093472.

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