510(k) K220717
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 2022
- Date Received
- March 11, 2022
- 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.