ORTHOMET WIRE FOR SUTURE, CERCLAGE— 510(k) K874919

Name: FDA 510(k) clearance K874919
Creator: U.S. Food and Drug Administration
Published: 1988-01-07

Substantially Equivalent

Orthomet, Inc.

FDA 510(k) clearance K874919 for ORTHOMET WIRE FOR SUTURE, CERCLAGE, Substantially Equivalent on 1988-01-07. Applicant: Orthomet, Inc.. Device class: 2.

Clearance details

Applicant: Orthomet, Inc.
Product code: Code JDQ
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 1987-12-03
Decision date: 1988-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY1995-04-26
K944752 — ORTHOMET RESURFACING FEMORAL COMPONENT1994-12-28
K930771 — PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM1994-11-30

Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.