Osteotrans -Mx Bioabsorbable Bone Fixation System
FDA 510(k) K061881 · Takiron Co., Ltd.
510(k) numberK061881
Submission
- Device name
- Osteotrans -Mx Bioabsorbable Bone Fixation System
- Applicant
- Takiron Co., Ltd.
Himeji, Hyogo, JP - Received
- July 3, 2006
- Decision date
- March 14, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Osteotrans -Mx Bioabsorbable Bone Fixation System cleared by the FDA?
Osteotrans -Mx Bioabsorbable Bone Fixation System (K061881) received a 510(k) decision of Substantially Equivalent on March 14, 2007, 254 days after the submission was received.
What is the product code of K061881?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.