OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE— 510(k) K984585

Name: FDA 510(k) clearance K984585
Creator: U.S. Food and Drug Administration
Published: 1999-02-24

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K984585 for OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE, Substantially Equivalent on 1999-02-24. Applicant: Osteonics Corp.. Device class: 2.

Clearance details

Applicant: Osteonics Corp.
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1998-12-24
Decision date: 1999-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

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K982798 — OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM1999-03-25
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Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.