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510(k) K172467

OMNI ARC Anteverted Neck Hip Stem by Omnilife Science — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2017
Date Received
August 15, 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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  • K153437 — Apex Revision Knee System (December 21, 2015)
  • K133381 — OMNI ARC MONOBLOCK HIP STEM (March 13, 2014)
  • K062489 — APEX HCLA ACETABULAR CUP LINERS (August 15, 2007)

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