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510(k) K192236

Fitmore Hip Stem by Zimmer GmbH — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2019
Date Received
August 19, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

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