Cleared Traditional

K091946 - VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX (FDA 510(k) Clearance)

K091946 · Stryker Spine · Orthopedic device

Sep 2009

Decision

87d

Days

Class 2

Risk

K091946 is an FDA 510(k) clearance for the VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on September 25, 2009, 87 days after receiving the submission on June 30, 2009.

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

Submission Details

510(k) Number	K091946 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 30, 2009
Decision Date	September 25, 2009
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF