Name: Predicase
Price: 199 USD

K-number	K252416
Device name	AETOS Shoulder System Meta Humeral Prosthesis Size 0
Applicant	Smith & Nephew, Inc.
Product code	KWS
Device class	Class II
Decision date	Oct 29, 2025
Decision	Substantially Equivalent
Regulation	888.3660

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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AETOS Shoulder System Meta Humeral Prosthesis Size 0

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