FDA.report

510(k) K132790

Device
INFIX ANTERIOR LUMBAR SYSTEM
Applicant
ZIMMER SPINE, INC
510(k) number
K132790
Product code
MAX  
Decision
Substantially Equivalent (SESE)
Decision date
2013-12-20
Date received
2013-09-06
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
DONNA SEMLAK
Address
7375 Bush Lake Rd. Minneapolis MN US 55441 55441

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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