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 | K192979 |
510k Number | K192979 |
Device Name: | KLS Martin Individual Patient Solutions (IPS) Planning System |
Classification | Orthopaedic Surgical Planning And Instrument Guides |
Applicant | KLS-Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville, FL 32246 |
Contact | Jennifer Damato |
Correspondent | Pam Martin KLS-Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville, FL 32246 |
Product Code | PBF |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-10-24 |
Decision Date | 2020-03-11 |