510(k) K911552

ANATOMIC TOE SYSTEM by Orthopaedic Biosystems — Product Code LZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1991
Date Received
April 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type