510(k) K211076
K211076 is an FDA 510(k) premarket notification submitted by Additive Orthopaedics, LLC for the device "Patient Specific Marking Guides". The FDA issued a decision of Substantially Equivalent on June 28, 2022. The device falls under product code PBF (Orthopaedic Surgical Planning And Instrument Guides), a Class II device regulated under 21 CFR 888.3030. Additive Orthopaedics, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 2022
- Date Received
- April 12, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthopaedic Surgical Planning And Instrument Guides
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.