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510(k) K040611

MODULAR RADIAL HEAD REPLACEMENT DEVICE by Biomet, Inc. — Product Code KWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2004
Date Received
March 8, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class
Class II
Regulation Number
888.3170
Review Panel
OR
Submission Type

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