Cleared Traditional

EXPANDABLE PEEK VBR IMPLANT

K040928 · Interpore Cross Intl. · Orthopedic
Aug 2004
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K040928 is an FDA 510(k) clearance for the EXPANDABLE PEEK VBR IMPLANT, 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 27, 2004, 140 days after receiving the submission on April 9, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K040928 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2004
Decision Date August 27, 2004
Days to Decision 140 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQP — Spinal Vertebral Body Replacement Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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