The following data is part of a premarket notification filed by Kls Martin L.p. with the FDA for Kls Martin Lss Plating System.
Device ID | K151983 |
510k Number | K151983 |
Device Name: | KLS Martin LSS Plating System |
Classification | Cerclage, Fixation |
Applicant | KLS MARTIN L.P. 11201 SAINT JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville, FL 32246 |
Contact | Jennifer Damato |
Correspondent | Gary Moore KLS MARTIN L.P. 11201 SAINT JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville, FL 32246 |
Product Code | JDQ |
CFR Regulation Number | 888.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-17 |
Decision Date | 2016-04-06 |
Summary: | summary |