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510(k) K173380

b-ONE® Total Hip System by B-One Ortho, Corp. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2018
Date Received
October 30, 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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  • K180446 — b-ONE Total Knee System (October 12, 2018)

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