Cleared Traditional

K163374 - ALLY™ Facet Screws (FDA 510(k) Clearance)

K163374 · Providence Medical Technology, Inc. · Orthopedic device

Feb 2017

Decision

77d

Days

Risk

K163374 is an FDA 510(k) clearance for the ALLY™ Facet Screws. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Providence Medical Technology, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on February 16, 2017, 77 days after receiving the submission on December 1, 2016.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K163374 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 01, 2016
Decision Date	February 16, 2017
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF