510(k) K222256
K222256 is an FDA 510(k) premarket notification submitted by Neo Medical SA for the device "BonOs® Inject Bone Cement; NEO Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on August 26, 2022. The device falls under product code PML (Bone Cement, Posterior Screw Augmentation), a Class II device regulated under 21 CFR 888.3027. Neo Medical SA has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 2022
- Date Received
- July 27, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bone Cement, Posterior Screw Augmentation
- Device Class
- Class II
- Regulation Number
- 888.3027
- Review Panel
- OR
- Submission Type
The device is intended to augment the fixation of screws in a posterior spinal system construct.