K201052 is an FDA 510(k) clearance for the KLS Martin Individual Patient Solutions (IPS) Planning System. This device is classified as a Cranial Surgical Planning And Instrument Guides (Class II - Special Controls, product code PPT).
Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on August 31, 2020, 132 days after receiving the submission on April 21, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310. 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..
| 510(k) Number | K201052 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2020 |
| Decision Date | August 31, 2020 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PPT — Cranial Surgical Planning And Instrument Guides |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4310 |
| Definition | 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. |