Cleared Special

K033837 - STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM (FDA 510(k) Clearance)

K033837 · Howmedica Osteonics Corp. · Orthopedic device

Jan 2004

Decision

29d

Days

Class 2

Risk

K033837 is an FDA 510(k) clearance for the STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on January 8, 2004, 29 days after receiving the submission on December 10, 2003.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K033837 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 10, 2003
Decision Date	January 08, 2004
Days to Decision	29 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF