Blackstone Pillar SA Partial Vertebral Body Replacement Device

• • Terminated Z-0641-2010 FDA Unclassified (pre-2012) ·initiated 19 Nov 2009 ·on shared 510(k) K081849

  The Pillar SA Implant Insertion Instrument 49-1100 may experience resistance in turning the activation knob while releasing an implant after intra-operative positioning.

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

510(k) Number

K081849 ↗

FDA Product Code

OVD

Device Class

Class II

Regulation

21 CFR Part 888.3080

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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