510(k) K213614
K213614 is an FDA 510(k) premarket notification submitted by Maxxion Medical, LLC for the device "Cannulated Screws". The FDA issued a decision of Substantially Equivalent on Aug 3, 2022. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 2022
- Date Received
- Nov 15, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)