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Satellite Spinal System

by Medtronic Sofamor Danek, Inc.

510(k) K051320

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK051320 Date9 Sep 2005ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0192-2008 FDA Unclassified (pre-2012) initiated 13 Sep 2007

    Surgical manual lacks information required as a condition of the 510(k) approval.

    • Terminated Z-1088-06 FDA Unclassified (pre-2012) initiated 14 Jan 2006 on shared 510(k) K051320

    Device distribution without marketing clearance

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Satellite Spinal System is an Intervertebral Fusion Device With Bone Graft designed for lumbar spinal fusion. It consists of solid-sphere implants intended to stabilize and promote bony fusion between adjacent vertebrae, restoring spinal alignment and reducing pain in degenerative or traumatic lumbar conditions.

This system is supplied as a sterile, single-use device and is classified as a Class III medical device under FDA regulations. It is intended for use in surgical settings, including operating rooms, and requires proper handling and storage as per manufacturer guidelines. The device holds FDA 510(k) clearance (K051320) and is distributed under the product code NVR.

Other devices from Medtronic Sofamor Danek, Inc.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of lumbar conditions is the Satellite Spinal System designed to address in surgical settings?

    The Satellite Spinal System is specifically designed for lumbar spinal fusion to stabilize the spine and promote bony fusion between adjacent vertebrae. It is intended for patients with degenerative or traumatic lumbar conditions where spinal alignment needs restoration and pain reduction through surgical intervention.

  • Is the Satellite Spinal System reusable, or is it meant for single-use only?

    The Satellite Spinal System is supplied as a sterile, single-use device. This design ensures patient safety and reduces the risk of infection or cross-contamination, which is critical in surgical settings where sterility is paramount.

  • How should the Satellite Spinal System be stored to maintain its integrity before use?

    Since it is a sterile, single-use device, the Satellite Spinal System must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Proper storage typically involves keeping it in its original packaging, away from moisture, extreme temperatures, and direct sunlight, until ready for surgical use.

  • What regulatory pathway was followed for FDA clearance of the Satellite Spinal System?

    The Satellite Spinal System received FDA clearance through a Traditional 510(k) review process, which compares it to a legally marketed predicate device to demonstrate substantial equivalence. The clearance number is K051320, and it falls under the product code NVR, confirming its classification as a Class III medical device.