The following data is part of a premarket notification filed by Kls Martin L.p. with the FDA for Kls Martin Rigid Fixation - Sterile.
Device ID | K060177 |
510k Number | K060177 |
Device Name: | KLS MARTIN RIGID FIXATION - STERILE |
Classification | Plate, Bone |
Applicant | KLS MARTIN L.P. 11239 ST. JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville, FL 32246 |
Contact | Jennifer Damato |
Correspondent | Jennifer Damato KLS MARTIN L.P. 11239 ST. JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville, FL 32246 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-23 |
Decision Date | 2006-04-18 |
Summary: | summary |