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510(k) K052596

MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 by Biopro, Inc. — Product Code KYI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 15, 2005
Date Received: September 21, 2005
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Prosthesis, Wrist, Carpal Trapezium
Device Class: Class II
Regulation Number: 888.3770
Review Panel: OR
Submission Type

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