Mini and Micro Fragments Reconstruction System-NEOFIX
FDA 510(k) clearance K142419 · decided 2014-12-16
Clearance details
- K-number
- K142419
- Device name
- Mini and Micro Fragments Reconstruction System-NEOFIX
- Applicant
- Neoortho Productos Orthopedicos S/A
- Decision
- Substantially Equivalent
- Date received
- 2014-08-28
- Decision date
- 2014-12-16
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Curitiba, BR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.