Mimix MP Bone Void Filler
FDA 510(k) K043280 · Biomet, Inc.
510(k) numberK043280
Submission
- Device name
- Mimix MP Bone Void Filler
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- November 26, 2004
- Decision date
- December 21, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Mimix MP Bone Void Filler cleared by the FDA?
Mimix MP Bone Void Filler (K043280) received a 510(k) decision of Substantially Equivalent on December 21, 2004, 25 days after the submission was received.
What is the product code of K043280?
The FDA product code is GXP – Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.