INTER-OS LIMB LENGTHENER— 510(k) K031875

Substantially Equivalent

Inter-Os Technologies

FDA 510(k) clearance K031875 for INTER-OS LIMB LENGTHENER, Substantially Equivalent on 2003-10-22. Applicant: Inter-Os Technologies.

Clearance details

Applicant: Inter-Os Technologies
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2003-06-17
Decision date: 2003-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lone Tree, CO, US

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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.