The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Kls Martin Individual Patient Solutions (ips) Planning System.
| Device ID | K182889 |
| 510k Number | K182889 |
| Device Name: | KLS Martin Individual Patient Solutions (IPS) Planning System |
| Classification | Cranial Surgical Planning And Instrument Guides |
| Applicant | KLS-Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville, FL 32246 |
| Contact | Jennifer Damato |
| Correspondent | Katie Rutland KLS-Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville, FL 32246 |
| Product Code | PPT |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-15 |
| Decision Date | 2019-07-26 |
| Summary: | summary |