Cleared Traditional

K110170 - RAPTOR FACET FIXATION SYSTEM (FDA 510(k) Clearance)

K110170 · Alphatec Spine, Inc. · Orthopedic device

Nov 2011

Decision

312d

Days

—

Risk

K110170 is an FDA 510(k) clearance for the RAPTOR FACET FIXATION SYSTEM. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Alphatec Spine, Inc. (Carlsnad, US). The FDA issued a Cleared decision on November 28, 2011, 312 days after receiving the submission on January 20, 2011.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K110170 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 20, 2011
Decision Date	November 28, 2011
Days to Decision	312 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF