MACROPOREDX DISTRACTOR SYSTEM— 510(k) K000992

Substantially Equivalent

Macropore Biosurgery, Inc.

FDA 510(k) clearance K000992 for MACROPOREDX DISTRACTOR SYSTEM, Substantially Equivalent on 2000-06-26. Applicant: Macropore Biosurgery, Inc..

Clearance details

Applicant: Macropore Biosurgery, Inc.
Product code: Code MQN
Advisory panel: Dental
Date received: 2000-03-28
Decision date: 2000-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQN

product code MQN

Injury: 346
Total: 346

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.