SIDE PLATE— 510(k) K905338

Substantially Equivalent

O'Tec Corp.

FDA 510(k) clearance K905338 for SIDE PLATE, Substantially Equivalent on 1990-12-11. Applicant: O'Tec Corp..

Clearance details

Applicant: O'Tec Corp.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 1990-11-28
Decision date: 1990-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.