HAIDER-UCR SPINAL SYSTEM— 510(k) K993503
Substantially EquivalentInternational Advanced Medical Enterprises, Inc.
FDA 510(k) clearance K993503 for HAIDER-UCR SPINAL SYSTEM, Substantially Equivalent on 2000-04-14. Applicant: International Advanced Medical Enterprises, Inc..
Clearance details
- Applicant
- International Advanced Medical Enterprises, Inc.
- Product code
- Code MNH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasant Hill, CA, US
Adverse events under product code MNH
product code MNH- Injury
- 978
- Malfunction
- 793
- Total
- 1,771
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.