MAGEC® System
FDA 510(k) clearance K171791 · decided 2017-08-31
Clearance details
- K-number
- K171791
- Device name
- MAGEC® System
- Applicant
- Nuvasive Specialized Orthopedics, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2017-06-16
- Decision date
- 2017-08-31
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- PGN
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Alisa Viejo, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MAGEC Spinal Bracing and Distraction System (K233593) | Nuvasive Specialized Orthopedics, Incorporated | 2024-02-06 |
| MAGEC® System (K201543) | Nuvasive Specialized Orthopedics, Inc. | 2020-07-30 |
| MAGEC® Spinal Bracing and Distraction System (K160352) | Nuvasive Specialized Orthopedics, Inc. | 2016-10-21 |
| MAGEC® Spinal Bracing and Distraction System (K161751) | Nuvasive Specialized Orthopedics, Inc. | 2016-09-02 |
| MAGEC 2 Spinal Bracing and Distraction System (K150885) | Ellipse Technologies, Incorporated | 2015-05-29 |
| MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (K141278) | Ellipse Technologies, Inc. | 2015-03-24 |
| MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (K140613) | Ellipse Technologies, Inc. | 2014-09-18 |
| ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (K140178) | Ellipse Technologies, Inc. | 2014-02-27 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; recall (Z-1657-2025) | Globus Medical, Inc. | 2025-04-23 |