FDA.report

510(k) K993067

Device
SILHOUETTE SPINAL FIXATION SYSTEM
Applicant
SULZER SPINE-TECH
510(k) number
K993067
Product code
KWP  
Decision
Substantially Equivalent (SESE)
Decision date
1999-11-16
Date received
1999-09-13
Regulation
888.3050
Classification name
Appliance, Fixation, Spinal Interlaminal
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
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

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases