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Colorado II Spinal System

by Sofamor Danek USA, Inc. 2 variants

510(k) K991031

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK991031 Date10 May 2000ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0125-2008 FDA Unclassified (pre-2012) initiated 10 Sep 2007 on shared 510(k) K991031

    Assembly may be compromised: Two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced.

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  • Withdrawn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
MNH
FDA applicant
Sofamor Danek USA,Inc.
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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