Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309, 3310)

• • Terminated Z-0554-2010 FDA Unclassified (pre-2012) ·initiated 20 Aug 2009

  The tip of the instrument may fracture during use.

510(k) Number

K082032 ↗

FDA Product Code

NKB

Models / Variants

3306)

Speedlink Transverse Connector (Models 3308

3309

3310)

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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