K182889 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 July 26, 2019, 284 days after receiving the submission on October 15, 2018.
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 | K182889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2018 |
| Decision Date | July 26, 2019 |
| Days to Decision | 284 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. |