Efficient Care 3D Planning— 510(k) K183544
Substantially EquivalentOrthosoft Inc (D/B/A Zimmer Cas)
FDA 510(k) clearance K183544 for Efficient Care 3D Planning, Substantially Equivalent on 2019-08-23. Applicant: Orthosoft Inc (D/B/A Zimmer Cas).
Clearance details
- Applicant
- Orthosoft Inc (D/B/A Zimmer Cas)
- Product code
- Code LLZ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montreal, CA
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.