MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.— 510(k) K884889

Substantially Equivalent

Protek, Inc.

FDA 510(k) clearance K884889 for MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP., Substantially Equivalent on 1989-02-27. Applicant: Protek, Inc..

Clearance details

Applicant: Protek, Inc.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1988-11-22
Decision date: 1989-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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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.