FDA Product Code
FDA Product Code PGN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3070
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233593 | MAGEC Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Incorporated | 2024-02-06 | Traditional | PDF ↗ |
| K201543 | MAGEC® System | Nuvasive Specialized Orthopedics, Inc. | 2020-07-30 | Traditional | PDF ↗ |
| K171791 | MAGEC® System | Nuvasive Specialized Orthopedics, Incorporated | 2017-08-31 | Traditional | PDF ↗ |
| K160352 | MAGEC® Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Inc. | 2016-10-21 | Traditional | PDF ↗ |
| K161751 | MAGEC® Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Inc. | 2016-09-02 | Traditional | PDF ↗ |
| K150885 | MAGEC 2 Spinal Bracing and Distraction System | Ellipse Technologies, Incorporated | 2015-05-29 | Traditional | PDF ↗ |
| K141278 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | Ellipse Technologies, Inc. | 2015-03-24 | Traditional | PDF ↗ |
| K140613 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | Ellipse Technologies, Inc. | 2014-09-18 | Traditional | PDF ↗ |
| K140178 | ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | Ellipse Technologies, Inc. | 2014-02-27 | Traditional | PDF ↗ |
Product code PGN · Class II · Orthopedic. Data: openFDA.