FDA.report

510(k) K130531

Device
ULTRAFUSE
Applicant
BAXTER HEALTHCARE CORP.
510(k) number
K130531
Product code
MQV  
Decision
Substantially Equivalent (SESE)
Decision date
2014-04-08
Date received
2013-03-01
Regulation
888.3045
Classification name
Filler, Bone Void, Calcium Compound
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
GRETCHEN MURRAY
Address
One Baxter Way Westlake Village CA US 91362 91362

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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