3I BIORESORBABLE FIXATION TACK— 510(k) K972480

Substantially Equivalent

Implant Innovations, Inc.

FDA 510(k) clearance K972480 for 3I BIORESORBABLE FIXATION TACK, Substantially Equivalent on 1997-12-23. Applicant: Implant Innovations, Inc..

Clearance details

Applicant: Implant Innovations, Inc.
Product code: Code DZL
Advisory panel: Dental
Date received: 1997-07-01
Decision date: 1997-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, 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.