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510(k) K171156

OMNI Anseris Hip Stem by Omnilife Science — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2017
Date Received
April 20, 2017
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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  • K133381 — OMNI ARC MONOBLOCK HIP STEM (March 13, 2014)
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