FDA.report

510(k) K121940

Device
LANX SPINAL FIXATION SYSTEM
Applicant
LANX, INC.
510(k) number
K121940
Product code
NKB  
Decision
Substantially Equivalent (SESE)
Decision date
2012-08-02
Date received
2012-07-02
Regulation
888.3070
Classification name
Thoracolumbosacral Pedicle Screw System
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
PATRICK HUNT
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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