Cleared Traditional

K010530 - GEO STRUCTURE
(FDA 510(k) Clearance)

K010530 · Interpore Cross Intl. · Orthopedic

Aug 2001

Decision

161d

Days

Class 2

Risk

K010530 is an FDA 510(k) clearance for the GEO STRUCTURE, 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 August 3, 2001, 161 days after receiving the submission on February 23, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K010530 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 2001
Decision Date	August 03, 2001
Days to Decision	161 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF