TRIPLE-FIX SPINAL FIXATION SYSTEM— 510(k) K992147
Substantially EquivalentAdvanced Spine Technology, Inc.
FDA 510(k) clearance K992147 for TRIPLE-FIX SPINAL FIXATION SYSTEM, Substantially Equivalent on 2000-02-28. Applicant: Advanced Spine Technology, Inc..
Clearance details
- Applicant
- Advanced Spine Technology, Inc.
- Product code
- Code MNI
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakland, CA, US
Adverse events under product code MNI
product code MNI- Injury
- 641
- Total
- 641
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.