MAGEC® System— 510(k) K171791
Substantially EquivalentNuvasive Specialized Orthopedics, Incorporated
FDA 510(k) clearance K171791 for MAGEC® System, Substantially Equivalent on 2017-08-31. Applicant: Nuvasive Specialized Orthopedics, Incorporated. Device class: 2.
Clearance details
- Applicant
- Nuvasive Specialized Orthopedics, Incorporated
- 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, Incorporated
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 K171791
K-number listed on FDA's recall record- Z-1657-2025 — MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
- Z-1898-2020 — NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spinal rod that is surgically implanted using appropriate NuVasive Reline, Reline Small Stature, and Armada fixation components (i.e. Pedicle screws, hooks and/or connectors, provided non-sterile, to be sterilized by the end user).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171791.
Data sourced from openFDA. This site is unofficial and independent of the FDA.