Cleared Traditional

OSTENE CT, AOC CT, OSTEOTENE, CERETENE

K102071 · Ceremed , Inc. · General & Plastic Surgery
Oct 2010
Decision
77d
Days
Risk

About This 510(k) Submission

K102071 is an FDA 510(k) clearance for the OSTENE CT, AOC CT, OSTEOTENE, CERETENE, a Wax, Bone, submitted by Ceremed , Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 8, 2010, 77 days after receiving the submission on July 23, 2010. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K102071 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2010
Decision Date October 08, 2010
Days to Decision 77 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code MTJ — Wax, Bone
Device Class

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