Prime and DYNASTY® Additive Manufacturing Shells— 510(k) K202705
Substantially EquivalentMicroport Orthopedics, Inc.
FDA 510(k) clearance K202705 for Prime and DYNASTY® Additive Manufacturing Shells, Substantially Equivalent on 2021-08-20. Applicant: Microport Orthopedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Microport Orthopedics, Inc.
- Product code
- Code OQG
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arlington, TN, US
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More clearances from Microport Orthopedics, Inc.
view allAdverse events under product code OQG
product code OQG- Injury
- 249
- Total
- 249
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.