Modification to Cd Horizon Spinal System

• 2 recalls, same reason

  • Terminated Z-0465-2012 FDA Unclassified (pre-2012) ·initiated 30 Nov 2011
  • Terminated Z-0464-2012 FDA Unclassified (pre-2012) ·initiated 30 Nov 2011

  One screw may be longer then size etched on the screw.

• 2 recalls, same reason

  • Terminated Z-2878-2011 FDA Unclassified (pre-2012) ·initiated 28 Jun 2011 ·on shared 510(k) K042025
  • Terminated Z-2875-2011 FDA Unclassified (pre-2012) ·initiated 28 Jun 2011 ·on shared 510(k) K042025

  Screws are longer then size etched on the screw.

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

1. 25 Aug 2004 Cleared FDA 510(k) K042025
2. 28 Jun 2011 Recall initiated FDA recalls Z-2878-2011
3. 28 Jun 2011 Recall initiated FDA recalls Z-2875-2011
4. 30 Nov 2011 Recall initiated FDA recalls Z-0465-2012
5. 30 Nov 2011 Recall initiated FDA recalls Z-0464-2012

510(k) Number

K042025 ↗

FDA product code

KWQ

Device class

Class II

Regulation

21 CFR Part 888.3060

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

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

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

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