510(k) K200768
K200768 is an FDA 510(k) premarket notification submitted by Morpheus AG for the device "Rebellion, Phantom Multi-Bite Kerrison Rongeur". The FDA issued a decision of Substantially Equivalent on May 4, 2021. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Morpheus AG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2021
- Date Received
- March 25, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rongeur, Manual
- Device Class
- Class II
- Regulation Number
- 882.4840
- Review Panel
- NE
- Submission Type