Cleared Traditional

K032812 - ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT (FDA 510(k) Clearance)

K032812 · Orthovita, Inc. · Orthopedic device

Dec 2003

Decision

90d

Days

Class 2

Risk

K032812 is an FDA 510(k) clearance for the ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).

Submitted by Orthovita, Inc. (Malver, US). The FDA issued a Cleared decision on December 8, 2003, 90 days after receiving the submission on September 9, 2003.

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

Submission Details

510(k) Number	K032812 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 09, 2003
Decision Date	December 08, 2003
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF