RECONSTRUCTION PLATE SYSTEM— 510(k) K924085

Name: FDA 510(k) clearance K924085
Creator: U.S. Food and Drug Administration
Published: 1992-12-17

Substantially Equivalent for Some Indications

Sofamor Danek Mfg., Inc.

FDA 510(k) clearance K924085 for RECONSTRUCTION PLATE SYSTEM, Substantially Equivalent for Some Indications on 1992-12-17. Applicant: Sofamor Danek Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Sofamor Danek Mfg., Inc.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1992-08-13
Decision date: 1992-12-17
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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K930191 — DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY1995-09-26
K932029 — TSRH SPINAL SCREWS1995-01-20
K922486 — DANEK TISSUE CUTTING AND REMOVAL SYSTEM1993-10-12
K930710 — SENTRY POSTERIOR SPINAL SYSTEM1993-10-01

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.