LEA PLAZA SPINAL FRAME SYSTEM— 510(k) K884585

Substantially Equivalent

Orthomet, Inc.

FDA 510(k) clearance K884585 for LEA PLAZA SPINAL FRAME SYSTEM, Substantially Equivalent on 1989-01-27. Applicant: Orthomet, Inc..

Clearance details

Applicant: Orthomet, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1988-11-02
Decision date: 1989-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.