Cleared Traditional

INTERGRO DBM

K031399 · Interpore Cross Intl. · Orthopedic
Feb 2005
Decision
655d
Days
Class 2
Risk

About This 510(k) Submission

K031399 is an FDA 510(k) clearance for the INTERGRO DBM, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on February 18, 2005, 655 days after receiving the submission on May 5, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K031399 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2003
Decision Date February 18, 2005
Days to Decision 655 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQV — Filler, Bone Void, Calcium Compound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

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