510(k) K140613
- Device
- MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
- Applicant
- ELLIPSE TECHNOLOGIES INC.
- 510(k) number
- K140613
- Product code
- PGN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-09-18
- Date received
- 2014-03-10
- Regulation
- 510(k) Premarket Notification
- Classification name
- Growing Rod System- Magnetic Actuation
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- John McIntyre
- Address
- 13900 Alton Pkwy. Suite 123 Irvine CA US 92618 92618
FDA Registration Numbers#
- 3003935342
- 3016438694
- 3006179046
- 1221763
- 1835251
- 3010047454
- 3006791286
- 3006128100
- 2022435
- 3005497913
- 3009973505
- 2029275
- 3009144915
Source Documents#
Other 510(k) Records For Product Code PGN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233593 | MAGEC Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Incorporated | 2024-02-06 |
| K201543 | MAGEC® System | Nuvasive Specialized Orthopedics, Inc. | 2020-07-30 |
| K171791 | MAGEC® System | Nuvasive Specialized Orthopedics, Incorporated | 2017-08-31 |
| K160352 | MAGEC® Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Inc. | 2016-10-21 |
| K161751 | MAGEC® Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Inc. | 2016-09-02 |
| K150885 | MAGEC 2 Spinal Bracing and Distraction System | Ellipse Technologies, Incorporated | 2015-05-29 |
| K141278 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | Ellipse Technologies, Inc. | 2015-03-24 |
| K140178 | ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | Ellipse Technologies, Inc. | 2014-02-27 |
Legacy Summary#
summary
FDA Review#
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