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Mercury Spinal System

by Spinal Elements, Inc. 6 variants

510(k) K071914

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

22 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK071914 Date12 Oct 2007ClearedStatusActive

Official records

Recalls

22 recalls · FDA

    • Terminated Z-1597-2015 FDA Class III initiated 9 Apr 2015

    Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device.

  • 21 recalls, same reason

    • Terminated Z-1266-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1247-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1250-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1264-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1252-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1256-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1262-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1248-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1265-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1246-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1260-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1251-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1261-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1258-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1249-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1253-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1259-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1254-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1257-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1255-2013 FDA Class III initiated 17 Apr 2009
    • Terminated Z-1263-2013 FDA Class III initiated 17 Apr 2009

    Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Timeline

23 dated events

  1. Recall initiated FDA recalls Z-1261-2013
  2. Recall initiated FDA recalls Z-1258-2013
  3. Recall initiated FDA recalls Z-1249-2013
  4. Recall initiated FDA recalls Z-1253-2013
  5. Recall initiated FDA recalls Z-1259-2013
  6. Recall initiated FDA recalls Z-1254-2013
  7. Recall initiated FDA recalls Z-1257-2013
  8. Recall initiated FDA recalls Z-1255-2013
  9. Recall initiated FDA recalls Z-1263-2013
  10. Recall initiated FDA recalls Z-1597-2015

13 earlier events are in the sections above.

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
NKB
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 26 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 Mercury Spinal System is a posterior thoracolumbar fixation system designed to correct and stabilize the spine through its versatile instruments and comprehensive implant offering. It is a 5.5mm titanium rod-based system featuring cannulated and non-cannulated multi-axial pedicle screws.

The system is supplied as a single-use device and is intended for use in conjunction with other fixation systems, such as the Spinal Elements Overwatch System or Lotus Posterior Cervical/Thoracic rod connectors. It is regulated under FDA 510(k) clearance and is not MRI safe.

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