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510(k) K042871

TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3 by Zimmer Trabecular — Product Code LPH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 21, 2004
Date Received: October 18, 2004
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class: Class II
Regulation Number: 888.3358
Review Panel: OR
Submission Type

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