Cleared Special

MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131

K014145 · Interpore Cross Intl. · Orthopedic

Jan 2002

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K014145 is an FDA 510(k) clearance for the MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on January 17, 2002, 30 days after receiving the submission on December 18, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K014145 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 2001
Decision Date	January 17, 2002
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF