HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY— 510(k) K901094

Substantially Equivalent

Grimm & Norton

FDA 510(k) clearance K901094 for HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY, Substantially Equivalent on 1990-04-27. Applicant: Grimm & Norton.

Clearance details

Applicant: Grimm & Norton
Product code: Code JEY
Advisory panel: Dental
Date received: 1990-03-07
Decision date: 1990-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plainview, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

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.