TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION— 510(k) K002152
Substantially EquivalentKLS-Martin L.P.
FDA 510(k) clearance K002152 for TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION, Substantially Equivalent on 2000-10-10. Applicant: KLS-Martin L.P..
Clearance details
- Applicant
- KLS-Martin L.P.
- Product code
- Code MQN
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Port Riche, FL, US
Adverse events under product code MQN
product code MQN- Injury
- 346
- Total
- 346
Source: openFDA MAUDE database, through . 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.