FDA.report

510(k) K123027

Device
CAPSTONE(R) SPINAL SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK, INC.
510(k) number
K123027
Product code
MAX  
Decision
Substantially Equivalent (SESE)
Decision date
2013-07-25
Date received
2012-09-28
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, 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
LEE GRANT
Address
1800 Pyramid Pl. Memphis TN US 38132 38132

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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