ISOLA PEDIATRIC COMPONENTS— 510(k) K962984

Name: FDA 510(k) clearance K962984
Creator: U.S. Food and Drug Administration
Published: 1996-11-27

Substantially Equivalent for Some Indications

Acromed Corp.

FDA 510(k) clearance K962984 for ISOLA PEDIATRIC COMPONENTS, Substantially Equivalent for Some Indications on 1996-11-27. Applicant: Acromed Corp.. Device class: 2.

Clearance details

Applicant: Acromed Corp.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 1996-08-01
Decision date: 1996-11-27
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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More clearances from Acromed Corp.

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K980485 — ISOLA SPINAL SYSTEM1998-10-21
K981714 — TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM1998-06-30
K981113 — PEDIATRIC PRC1998-05-29
K981274 — ACROMED TIMX PLATE BASED LOW BACK SYSTEM1998-04-29
K980228 — UNIVERSITY PLATE ANTERIOR SYSTEM1998-04-14

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.