Intra-Lock Bone Fixation System— 510(k) K171831

Substantially Equivalent

Intra-Lock International, Inc.

FDA 510(k) clearance K171831 for Intra-Lock Bone Fixation System, Substantially Equivalent on 2017-10-26. Applicant: Intra-Lock International, Inc..

Clearance details

Applicant: Intra-Lock International, Inc.
Product code: Code DZL
Advisory panel: Dental
Date received: 2017-06-20
Decision date: 2017-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

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Adverse events under product code DZL

product code DZL

Injury: 168
Total: 168

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.