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510(k) K093235

RINGLOC + HYBRID ACETABULAR SYSTEM by Biomet, Inc. — Product Code KWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2010
Date Received
October 15, 2009
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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  • K111910 — GLADIATOR HIP STEM (October 14, 2011)
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