FDA.report

510(k) K141489

Device
LINOS MOH HAND PLATING SYSTEM
Applicant
KLS MARTIN L.P.
510(k) number
K141489
Product code
HRS  
Decision
Substantially Equivalent (SESE)
Decision date
2014-07-24
Date received
2014-06-05
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
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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