FDA.report

510(k) K980288

Device
SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM
Applicant
SPINE-TECH, INC.
510(k) number
K980288
Product code
KWP  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1998-07-29
Date received
1998-01-26
Regulation
888.3050
Classification name
Appliance, Fixation, Spinal Interlaminal
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
DAVID A CANNISTRACI
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 not indicated by FDA · openFDA JSON

Legacy Summary

summary

FDA Review

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