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510(k) K113271

METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS by Biomet Manufacturing, Inc. — Product Code KWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2012
Date Received
November 4, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3330
Review Panel
OR
Submission Type

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Other clearances for product code KWA

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  • K111699 — PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM (August 19, 2011)