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CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System

by Medtronic Sofamor Danek USA, Inc.

510(k) K171107

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171107 Date26 Sep 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
MAX
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Capstone Control Spinal System and Capstone Control PTC Spinal System are spinal fusion devices. They are intended for use in patients diagnosed with degenerative disc disease at one or two contiguous levels from L2 to S1, including patients who may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

This system is authorized for use via FDA 510k clearance. It is designed to address discogenic back pain associated with confirmed disc degeneration.

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Questions

AI-generated answers, 6 Oct 2026

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

  • What is the intended use of the Capstone Control Spinal System?

    The Capstone Control and Capstone Control PTC Spinal Systems are spinal fusion devices designed to treat discogenic back pain associated with confirmed degenerative disc disease.

  • Which patient populations are candidates for this spinal system?

    These systems are indicated for patients diagnosed with degenerative disc disease at one or two contiguous levels from L2 to S1, including those with up to Grade 1 spondylolisthesis or retrolisthesis.

  • What is the regulatory status of the Capstone Control Spinal System?

    The Capstone Control Spinal System and Capstone Control PTC Spinal System are authorized for use via FDA 510k clearance, under the K171107 submission.