510(k) K212545
K212545 is an FDA 510(k) premarket notification submitted by Neosteo for the device "FlexitSystem Knee osteotomy system". The FDA issued a decision of Substantially Equivalent on February 11, 2022. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Neosteo has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 2022
- Date Received
- August 12, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type