ANTERIOR DYNAMIZED SYSTEM— 510(k) K953978

Name: FDA 510(k) clearance K953978
Creator: U.S. Food and Drug Administration
Published: 1997-02-19

Substantially Equivalent

Acromed Corp.

FDA 510(k) clearance K953978 for ANTERIOR DYNAMIZED SYSTEM, Substantially Equivalent on 1997-02-19. Applicant: Acromed Corp.. Device class: 2.

Clearance details

Applicant: Acromed Corp.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 1995-08-23
Decision date: 1997-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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K981274 — ACROMED TIMX PLATE BASED LOW BACK SYSTEM1998-04-29
K980228 — UNIVERSITY PLATE ANTERIOR SYSTEM1998-04-14

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.