Satellite Spinal System Modification
by Medtronic Sofamor Danek, Inc.
510(k) K060415
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESU | NumberK060415 | Date5 Jan 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Modification to: Satellite Spinal System
- 510(k) Number
- FDA product code
- NVR
- FDA applicant
- Medtronic Sofamor Danek
- Device class
- Class III
- Advisory committee
- Unknown
- FDA decision
- SESU
Overview
AI-generated summary, 18 Sep 2026
The Satellite Spinal System Modification is an Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar, designed to facilitate spinal stabilization and fusion in the lumbar region. It incorporates solid-sphere components to promote bony integration and structural support between vertebrae, aiding in the treatment of degenerative disc disease or spinal instability.
This device is supplied as a modification to the original Satellite Spinal System and is classified under FDA 510(k) clearance (K060415) as a Class III medical device. It is intended for surgical use in controlled operating room environments and requires sterile handling. The system is reusable per manufacturer specifications, though individual components may vary in sterility and single-use requirements. No MRI safety information is specified, and storage conditions align with standard orthopedic implant protocols.
Other devices from Medtronic Sofamor Danek, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Satellite Spinal System Modification in lumbar spine surgery?
The Satellite Spinal System Modification is designed to facilitate spinal stabilization and fusion in the lumbar region by using solid-sphere components. These components promote bony integration and structural support between vertebrae, which helps address conditions like degenerative disc disease or spinal instability.
Is this device intended for single-use or can it be reused according to manufacturer guidelines?
The Satellite Spinal System Modification is classified as reusable per the manufacturer’s specifications, though individual components within the system may have varying sterility and single-use requirements. Sterile handling is required, especially in the controlled operating room environment where it is used.
How should the Satellite Spinal System Modification be stored to maintain its integrity?
Storage follows standard orthopedic implant protocols, though specific conditions like temperature or humidity are not detailed in the provided data. Since it is intended for surgical use, it should be kept in a clean, dry environment to prevent contamination until use.
Are there any restrictions on using this device with MRI machines?
The provided data does not specify MRI safety information for the Satellite Spinal System Modification, so its compatibility with MRI machines cannot be confirmed. Caution should be exercised, and pre-procedural checks are recommended if MRI imaging is planned.
What regulatory pathway was followed for the approval of this modification?
The Satellite Spinal System Modification received FDA clearance through a 510(k) submission (K060415) under the traditional review pathway. It is classified as a Class III medical device, indicating it is subject to stringent regulatory oversight due to its surgical use and potential risks.