Craniofacial Calcium Phosphate Ceramic Bone Filler
FDA 510(k) K990290 · Biomet, Inc.
510(k) numberK990290
Submission
- Device name
- Craniofacial Calcium Phosphate Ceramic Bone Filler
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- January 29, 1999
- Decision date
- November 18, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Craniofacial Calcium Phosphate Ceramic Bone Filler cleared by the FDA?
Craniofacial Calcium Phosphate Ceramic Bone Filler (K990290) received a 510(k) decision of Substantially Equivalent on November 18, 1999, 293 days after the submission was received.
What is the product code of K990290?
The FDA product code is GXP – Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.