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510(k) K062489

APEX HCLA ACETABULAR CUP LINERS by Omnilife Science — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2007
Date Received
August 25, 2006
Clearance Type
Traditional
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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  • K133381 — OMNI ARC MONOBLOCK HIP STEM (March 13, 2014)

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