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510(k) K062408

SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD by Smith & Nephew, Inc. — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2006
Date Received
August 17, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

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  • K192995 — OsteoRemedies Hip Spacer System (January 10, 2020)
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