FDA.report

510(k) K992276

Device
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
Applicant
SULZER SPINE-TECH
510(k) number
K992276
Product code
MNI  
Decision
Substantially Equivalent (SESE)
Decision date
1999-10-01
Date received
1999-07-07
Regulation
888.3070
Classification name
Orthosis, Spinal Pedicle Fixation
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
JANELL A COLLEY
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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