Cleared Traditional

K012773 - DISCOVERY FACET SCREW FIXATION SYSTEM
(FDA 510(k) Clearance)

K012773 · Depuyacromed · Orthopedic

Nov 2001

Decision

88d

Days

—

Risk

K012773 is an FDA 510(k) clearance for the DISCOVERY FACET SCREW FIXATION SYSTEM, a System, Facet Screw Spinal Device, submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on November 16, 2001, 88 days after receiving the submission on August 20, 2001. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number	K012773 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 2001
Decision Date	November 16, 2001
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF