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FDA 510(k)

JARVIS Diaphyseal Stem Standard

K-Number: K253345 · 2025-10-29

ApplicantFH Industrie
Decision Date2025-10-29
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JARVIS Diaphyseal Stem Standard is a medical device manufactured by FH Industrie. It received FDA 510(k) clearance on 2025-10-29 under approval number K253345. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JARVIS Diaphyseal Stem Standard?

JARVIS Diaphyseal Stem Standard is a medical device that received FDA 510(k) clearance on 2025-10-29. It is manufactured by FH Industrie. The 510(k) number is K253345.

When was JARVIS Diaphyseal Stem Standard approved by the FDA?

JARVIS Diaphyseal Stem Standard received FDA 510(k) clearance on 2025-10-29, under approval number K253345.

What company makes JARVIS Diaphyseal Stem Standard?

JARVIS Diaphyseal Stem Standard is manufactured by FH Industrie.

What is the FDA product code for JARVIS Diaphyseal Stem Standard?

The FDA product code for JARVIS Diaphyseal Stem Standard is PHX.

Related Clinical Trials

NCT07536581 Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails NOT_YET_RECRUITING

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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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