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FDA 510(k)

Montross Extremity Medical Hemi Implant System

K-Number: K221220 · 2023-04-19

ApplicantMontross Extremity Medical
Decision Date2023-04-19
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Montross Extremity Medical Hemi Implant System is a medical device manufactured by Montross Extremity Medical. It received FDA 510(k) clearance on 2023-04-19 under approval number K221220. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Montross Extremity Medical Hemi Implant System?

Montross Extremity Medical Hemi Implant System is a medical device that received FDA 510(k) clearance on 2023-04-19. It is manufactured by Montross Extremity Medical. The 510(k) number is K221220.

When was Montross Extremity Medical Hemi Implant System approved by the FDA?

Montross Extremity Medical Hemi Implant System received FDA 510(k) clearance on 2023-04-19, under approval number K221220.

What company makes Montross Extremity Medical Hemi Implant System?

Montross Extremity Medical Hemi Implant System is manufactured by Montross Extremity Medical.

What is the FDA product code for Montross Extremity Medical Hemi Implant System?

The FDA product code for Montross Extremity Medical Hemi Implant System is KWD.

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) 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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