FDA.report

510(k) K090316

Device
MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM
Applicant
LANX, INC.
510(k) number
K090316
Product code
KWQ  
Decision
Substantially Equivalent (SESE)
Decision date
2009-04-07
Date received
2009-02-09
Regulation
888.3060
Classification name
Appliance, Fixation, Spinal Intervertebral Body
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
ANDREW LAMBORNE
Address
390 Interlocken Crescent Suite 890 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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