Z-PLATE ANTERIOR FIXATION SYSTEM— 510(k) K922543

Name: FDA 510(k) clearance K922543
Creator: U.S. Food and Drug Administration
Published: 1993-05-19

Substantially Equivalent for Some Indications

Sofamor Danek Mfg., Inc.

FDA 510(k) clearance K922543 for Z-PLATE ANTERIOR FIXATION SYSTEM, Substantially Equivalent for Some Indications on 1993-05-19. Applicant: Sofamor Danek Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Sofamor Danek Mfg., Inc.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 1992-05-29
Decision date: 1993-05-19
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Sofamor Danek Mfg., Inc.

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K936294 — SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS1995-12-19
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 KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.