SYNERGY 4.0 MM, 4.5 MM VLS SCREWS— 510(k) K011437
Substantially EquivalentInterpore Cross Intl.
FDA 510(k) clearance K011437 for SYNERGY 4.0 MM, 4.5 MM VLS SCREWS, Substantially Equivalent on 2001-06-06. Applicant: Interpore Cross Intl..
Clearance details
- Applicant
- Interpore Cross Intl.
- Product code
- Code MNI
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, 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.