510(k) K051093
K051093 is an FDA 510(k) premarket notification submitted by Osteopore, Inc. for the device "OSTEOPORE PCL SCAFFOLD". The FDA issued a decision of Substantially Equivalent on March 17, 2006. The device falls under product code GXP (Methyl Methacrylate For Cranioplasty), a Class II device regulated under 21 CFR 882.5300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2006
- Date Received
- April 28, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Methyl Methacrylate For Cranioplasty
- Device Class
- Class II
- Regulation Number
- 882.5300
- Review Panel
- NE
- Submission Type