FDA.report

510(k) K123767

Device
LANX FUSION SYSTEM- SA
Applicant
LANX, INC.
510(k) number
K123767
Product code
OVD  
Decision
Substantially Equivalent (SESE)
Decision date
2013-03-18
Date received
2012-12-07
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
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
Alan Burkholder
Address
310 Interlocken Pkwy. Suite 120 Broomfield CO US 80021 80021

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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