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FDA 510(k)

EVOS Pelvic and Acetabular System

K-Number: K241666 · 2025-02-19

ApplicantSmith & Nephew
Decision Date2025-02-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOS Pelvic and Acetabular System is a medical device manufactured by Smith & Nephew. It received FDA 510(k) clearance on 2025-02-19 under approval number K241666. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVOS Pelvic and Acetabular System?

EVOS Pelvic and Acetabular System is a medical device that received FDA 510(k) clearance on 2025-02-19. It is manufactured by Smith & Nephew. The 510(k) number is K241666.

When was EVOS Pelvic and Acetabular System approved by the FDA?

EVOS Pelvic and Acetabular System received FDA 510(k) clearance on 2025-02-19, under approval number K241666.

What company makes EVOS Pelvic and Acetabular System?

EVOS Pelvic and Acetabular System is manufactured by Smith & Nephew.

What is the FDA product code for EVOS Pelvic and Acetabular System?

The FDA product code for EVOS Pelvic and Acetabular System is HRS.

Related Clinical Trials

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Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026)

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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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