Name: Predicase
Price: 199 USD

K-number	K250074
Device name	HYALEX® MTP Hemiarthroplasty Implant
Applicant	Hyalex Orthopaedics, Inc.
Product code	KWD
Device class	Class II
Decision date	Apr 3, 2026
Decision	Substantially Equivalent
Regulation	888.3730

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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HYALEX® MTP Hemiarthroplasty Implant

Everything you need for a 510(k) submission. Nothing you don't.