ANCHORMAN Tibial Ligament Fixation Device— 510(k) K170388

Substantially Equivalent

Summit Medical , Ltd.

FDA 510(k) clearance K170388 for ANCHORMAN Tibial Ligament Fixation Device, Substantially Equivalent on 2017-07-25. Applicant: Summit Medical , Ltd..

Clearance details

Applicant: Summit Medical , Ltd.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2017-02-08
Decision date: 2017-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bourton On The Water, GB

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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.