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FDA 510(k)

AETOS Shoulder System Meta Humeral Prosthesis Size 0

K-Number: K252416 · 2025-10-29

ApplicantSmith & Nephew, Inc.
Decision Date2025-10-29
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AETOS Shoulder System Meta Humeral Prosthesis Size 0 is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2025-10-29 under approval number K252416. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AETOS Shoulder System Meta Humeral Prosthesis Size 0?

AETOS Shoulder System Meta Humeral Prosthesis Size 0 is a medical device that received FDA 510(k) clearance on 2025-10-29. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K252416.

When was AETOS Shoulder System Meta Humeral Prosthesis Size 0 approved by the FDA?

AETOS Shoulder System Meta Humeral Prosthesis Size 0 received FDA 510(k) clearance on 2025-10-29, under approval number K252416.

What company makes AETOS Shoulder System Meta Humeral Prosthesis Size 0?

AETOS Shoulder System Meta Humeral Prosthesis Size 0 is manufactured by Smith & Nephew, Inc..

What is the FDA product code for AETOS Shoulder System Meta Humeral Prosthesis Size 0?

The FDA product code for AETOS Shoulder System Meta Humeral Prosthesis Size 0 is KWS.

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Related Devices (Code: KWS)

K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S. K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)Stryker GmbH K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. K161108Arthrex VaultLock GlenoidArthrex, Inc. K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc. K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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