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510(k) K042841

M2A/C2A ACETABULAR SYSTEM by Biomet, Inc. — Product Code JDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2004
Date Received
October 14, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3320
Review Panel
OR
Submission Type

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Other clearances for product code JDL

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  • K041586 — PROFEMUR S HIP STEM (July 9, 2004)
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  • K004043 — METAL TRANSCEND ARTICULATION SYSTEM (July 13, 2001)
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