510(k) K180050
K180050 is an FDA 510(k) premarket notification submitted by Curvafix, Inc. for the device "CurvaFix Intramedullary Rodscrew System". The FDA issued a decision of Substantially Equivalent on March 1, 2019. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Curvafix, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 2019
- Date Received
- January 8, 2018
- 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