PSI SKULL CLAMP— 510(k) K002276

Substantially Equivalent

V. Mueller Neuro/Spine

FDA 510(k) clearance K002276 for PSI SKULL CLAMP, Substantially Equivalent on 2000-08-29. Applicant: V. Mueller Neuro/Spine.

Clearance details

Applicant: V. Mueller Neuro/Spine
Product code: Code HBL
Advisory panel: Neurology
Date received: 2000-07-26
Decision date: 2000-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Carlos, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBL

product code HBL

Death: 3
Injury: 753
Malfunction: 1,421
Total: 2,177

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.