FDA.report

510(k) K974435

Device
Michelson Anterior Cervical Plate System
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
510(k) number
K974435
Product code
KWQ
Decision
Substantially Equivalent for Some Indications (SN)
Decision date
1998-02-19
Date received
1997-11-24
Regulation
888.3060
Classification name
Appliance, Fixation, Spinal Intervertebral Body
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
DAN REGAN
Address
5677 Airline Rd. Arlington TN US 38002 38002

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

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