510(k) K243912
K243912 is an FDA 510(k) premarket notification submitted by Newclip Technics for the device "Newclip Patient-matched instrumentation non sterile PSI". The FDA issued a decision of Substantially Equivalent on February 13, 2025. The device falls under product code PBF (Orthopaedic Surgical Planning And Instrument Guides), a Class II device regulated under 21 CFR 888.3030. Newclip Technics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2025
- Date Received
- December 19, 2024
- 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.