FDA.report

510(k) K131980

Device
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
Applicant
ZIMMER SPINE, INC.
510(k) number
K131980
Product code
NKB  
Decision
Substantially Equivalent (SESE)
Decision date
2013-09-04
Date received
2013-06-28
Regulation
888.3070
Classification name
Thoracolumbosacral Pedicle Screw System
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
JONATHAN GILBERT
Address
7375 Bush Lake Rd. Minneapolis MN US 55439 55439

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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