SOFT TISSUE SUTURE WASHER— 510(k) K991135

Name: FDA 510(k) clearance K991135
Creator: U.S. Food and Drug Administration
Published: 1999-04-29

Substantially Equivalent

Depuy, Inc.

FDA 510(k) clearance K991135 for SOFT TISSUE SUTURE WASHER, Substantially Equivalent on 1999-04-29. Applicant: Depuy, Inc.. Device class: 2.

Clearance details

Applicant: Depuy, Inc.
Product code: Code HTN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1999-04-05
Decision date: 1999-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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