MicroPort Orthopedics Total Hip Systems MR Labeling— 510(k) K173898
Substantially EquivalentMicroport Orthopedics Inc. (Mpo)
FDA 510(k) clearance K173898 for MicroPort Orthopedics Total Hip Systems MR Labeling, Substantially Equivalent on 2018-09-20. Applicant: Microport Orthopedics Inc. (Mpo).
Clearance details
- Applicant
- Microport Orthopedics Inc. (Mpo)
- Product code
- Code LZO
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arlington, TN, US
Adverse events under product code LZO
product code LZO- Death
- 17
- Injury
- 12,942
- Malfunction
- 1,756
- Total
- 14,715
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.