MAGEC® System— 510(k) K201543
Substantially EquivalentNuvasive Specialized Orthopedics, Inc.
FDA 510(k) clearance K201543 for MAGEC® System, Substantially Equivalent on 2020-07-30. Applicant: Nuvasive Specialized Orthopedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Nuvasive Specialized Orthopedics, Inc.
- Product code
- Code PGN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alisa Viejo, CA, US
Recent devices under product code PGN
view allMore clearances from Nuvasive Specialized Orthopedics, Inc.
view allAdverse events under product code PGN
product code PGN- Injury
- 253
- Malfunction
- 633
- Total
- 886
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 →
Recalls naming K201543
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201543.
Data sourced from openFDA. This site is unofficial and independent of the FDA.