PMT SUBARACHNOID SCREW, MODEL NO.1350-2— 510(k) K883115

Substantially Equivalent

Pmt Corp.

FDA 510(k) clearance K883115 for PMT SUBARACHNOID SCREW, MODEL NO.1350-2, Substantially Equivalent on 1988-08-29. Applicant: Pmt Corp..

Clearance details

Applicant: Pmt Corp.
Product code: Code GWM
Advisory panel: Neurology
Date received: 1988-07-25
Decision date: 1988-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chanhassen, MN, US

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Adverse events under product code GWM

product code GWM

Death: 21
Injury: 732
Malfunction: 2,063
Other: 1
Total: 2,817

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.