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510(k) K004043

METAL TRANSCEND ARTICULATION SYSTEM by Wrightmedicaltechnologyinc — Product Code JDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2001
Date Received
December 29, 2000
Clearance Type
Abbreviated
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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  • K041114 — PROFEMUR TAPERED HIP STEM (May 28, 2004)
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