Cleared Traditional

K031657 - STRYKER SPINE OASYS BONE SCREW (FDA 510(k) Clearance)

K031657 · Howmedica Osteonics Corp. · Orthopedic device

Aug 2003

Decision

86d

Days

—

Risk

K031657 is an FDA 510(k) clearance for the STRYKER SPINE OASYS BONE SCREW. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on August 22, 2003, 86 days after receiving the submission on May 28, 2003.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K031657 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 28, 2003
Decision Date	August 22, 2003
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF