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510(k) K021714

RT-PLUS PE INSERT CLAMP by Plus Orthopedics — Product Code KRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2002
Date Received
May 24, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3510
Review Panel
OR
Submission Type

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