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510(k) K133381

OMNI ARC MONOBLOCK HIP STEM by Omnilife Science — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2014
Date Received
November 4, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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  • K062489 — APEX HCLA ACETABULAR CUP LINERS (August 15, 2007)

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