Cleared Traditional

K060762 - AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM (FDA 510(k) Clearance)

K060762 · Aesculap, Inc. · Orthopedic device

Sep 2006

Decision

177d

Days

Class 2

Risk

K060762 is an FDA 510(k) clearance for the AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on September 14, 2006, 177 days after receiving the submission on March 21, 2006.

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

Submission Details

510(k) Number	K060762 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 21, 2006
Decision Date	September 14, 2006
Days to Decision	177 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF