FDA.report

510(k) K151983

Device
KLS Martin LSS Plating System
Applicant
KLS MARTIN L.P.
510(k) number
K151983
Product code
JDQ  
Decision
Substantially Equivalent (SESE)
Decision date
2016-04-06
Date received
2015-07-17
Regulation
888.3010
Classification name
Cerclage, Fixation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JENNIFER DAMATO
Address
11201 Saint Johns Industrial Pkwy. S Jacksonville FL US 32246 32246

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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