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510(k) K202768

KOSMO Femoral Stem by B-One Ortho, Corp. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2021
Date Received
September 21, 2020
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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