GENEROS SB SMALL BONE DISTRACTION IMPLANT— 510(k) K051162

Substantially Equivalent

Orthonetx, Inc.

FDA 510(k) clearance K051162 for GENEROS SB SMALL BONE DISTRACTION IMPLANT, Substantially Equivalent on 2005-07-19. Applicant: Orthonetx, Inc..

Clearance details

Applicant: Orthonetx, Inc.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2005-05-05
Decision date: 2005-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Superior, 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.