Cleared Traditional

K092464 - SPINEOLOGY FACET SCREW (FDA 510(k) Clearance)

K092464 · Spineology, Inc. · Orthopedic device

Nov 2009

Decision

90d

Days

—

Risk

K092464 is an FDA 510(k) clearance for the SPINEOLOGY FACET SCREW. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Spineology, Inc. (St. Paul, US). The FDA issued a Cleared decision on November 9, 2009, 90 days after receiving the submission on August 11, 2009.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K092464 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 11, 2009
Decision Date	November 09, 2009
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF