Clearance Summary
Patient Specific Marking Guides received FDA 510(k) clearance under submission number K211076, sponsored by Additive Orthopaedics, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2022-06-28.
- Submission: K211076
- Applicant / Sponsor: Additive Orthopaedics, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2022-06-28
Classification & Regulation
This clearance is catalogued under FDA product code PBF and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.