510(k) K163156
K163156 is an FDA 510(k) premarket notification submitted by Materialise NV for the device "SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides". The FDA issued a decision of Substantially Equivalent on Jan 18, 2017. The device falls under product code PBF (Orthopaedic Surgical Planning And Instrument Guides), a Class II device regulated under 21 CFR 888.3030. Materialise NV has 60 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 18, 2017
- Date Received
- Nov 10, 2016
- 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
- 510(k)
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.