510(k) K890185

C-S IMPACTOR by Orthopedic Systems, Inc. — Product Code LYP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1989
Date Received
January 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type