510(k) K162864
K162864 is an FDA 510(k) premarket notification submitted by Skeletal Kinetics, LLC for the device "OsteoVation Impact". The FDA issued a decision of Substantially Equivalent on January 13, 2017. The device falls under product code GXP (Methyl Methacrylate For Cranioplasty), a Class II device regulated under 21 CFR 882.5300. Skeletal Kinetics, LLC has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2017
- Date Received
- October 13, 2016
- 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