Cleared Special

AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12

K050440 · Ceremed , Inc. · General & Plastic Surgery
Mar 2005
Decision
30d
Days
—
Risk

About This 510(k) Submission

K050440 is an FDA 510(k) clearance for the AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12, a Wax, Bone, submitted by Ceremed , Inc. (Los Angeles, US). The FDA issued a Cleared decision on March 24, 2005, 30 days after receiving the submission on February 22, 2005. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K050440 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2005
Decision Date March 24, 2005
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code MTJ — Wax, Bone
Device Class —

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