FDA.report

510(k) K070169

Device
KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE
Applicant
KLS MARTIN L.P.
510(k) number
K070169
Product code
HRS  
Decision
Substantially Equivalent (SESE)
Decision date
2007-03-26
Date received
2007-01-18
Regulation
888.3030
Classification name
Plate, Fixation, Bone
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
11239 St. 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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