RAYLOR(TM) MALLET— 510(k) K864422

Substantially Equivalent

Cedar Surgical, Inc.

FDA 510(k) clearance K864422 for RAYLOR(TM) MALLET, Substantially Equivalent on 1986-11-24. Applicant: Cedar Surgical, Inc..

Clearance details

Applicant: Cedar Surgical, Inc.
Product code: Code HWA
Advisory panel: Orthopedic
Date received: 1986-11-10
Decision date: 1986-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

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Adverse events under product code HWA

product code HWA

Malfunction: 12,146
Other: 2
Total: 12,148

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.