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510(k) K241875

TheRay Collared and Collarless Femoral Stem by Nextstep Arthropedix — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2024
Date Received
June 28, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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