510(k) K201052
K201052 is an FDA 510(k) premarket notification submitted by KLS-Martin L.P. for the device "KLS Martin Individual Patient Solutions (IPS) Planning System". The FDA issued a decision of Substantially Equivalent on August 31, 2020. The device falls under product code PPT (Cranial Surgical Planning And Instrument Guides), a Class II device regulated under 21 CFR 882.4310. KLS-Martin L.P. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2020
- Date Received
- April 21, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cranial Surgical Planning And Instrument Guides
- Device Class
- Class II
- Regulation Number
- 882.4310
- Review Panel
- NE
- Submission Type
Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures.