AMT SPINAL SYSTEM— 510(k) K002059
Substantially EquivalentMicron Precision Engineering, Inc.
FDA 510(k) clearance K002059 for AMT SPINAL SYSTEM, Substantially Equivalent on 2000-11-13. Applicant: Micron Precision Engineering, Inc..
Clearance details
- Applicant
- Micron Precision Engineering, Inc.
- Product code
- Code KWP
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Pedro, CA, US
Adverse events under product code KWP
product code KWP- Death
- 7
- Injury
- 1,539
- Malfunction
- 1,519
- Total
- 3,065
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.