510(k) K201561
K201561 is an FDA 510(k) premarket notification submitted by Neoss Limited for the device "Membrane Screws and Membrane Tacks". The FDA issued a decision of Substantially Equivalent on October 5, 2020. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2020
- Date Received
- June 10, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Intraosseous
- Device Class
- Class II
- Regulation Number
- 872.4880
- Review Panel
- DE
- Submission Type