Modification to Incompass Spinal Fixation System

• • Terminated Z-1592-2008 FDA Unclassified (pre-2012) ·initiated 24 Mar 2008

  Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.

510(k) Number

K023644 ↗

FDA Product Code

MNI

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Spinal Concepts, Inc. →