Cleared Traditional

PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L

K980817 · Interpore Intl. · Orthopedic
Sep 1998
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K980817 is an FDA 510(k) clearance for the PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Interpore Intl. (Irvine, US). The FDA issued a Cleared decision on September 25, 1998, 206 days after receiving the submission on March 3, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K980817 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1998
Decision Date September 25, 1998
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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