Cleared Traditional

PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30

K004003 · Interpore Cross Intl. · Orthopedic
Jul 2001
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K004003 is an FDA 510(k) clearance for the PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30, 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 July 19, 2001, 206 days after receiving the submission on December 25, 2000. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K004003 FDA.gov
FDA Decision Cleared SESE
Date Received December 25, 2000
Decision Date July 19, 2001
Days to Decision 206 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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