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FDA 510(k)

Medline UNITE IM Fibula Implant

K-Number: K220511 · 2022-03-22

ApplicantMedline Industries, LP
Decision Date2022-03-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline UNITE IM Fibula Implant is a medical device manufactured by Medline Industries, LP. It received FDA 510(k) clearance on 2022-03-22 under approval number K220511. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline UNITE IM Fibula Implant?

Medline UNITE IM Fibula Implant is a medical device that received FDA 510(k) clearance on 2022-03-22. It is manufactured by Medline Industries, LP. The 510(k) number is K220511.

When was Medline UNITE IM Fibula Implant approved by the FDA?

Medline UNITE IM Fibula Implant received FDA 510(k) clearance on 2022-03-22, under approval number K220511.

What company makes Medline UNITE IM Fibula Implant?

Medline UNITE IM Fibula Implant is manufactured by Medline Industries, LP.

What is the FDA product code for Medline UNITE IM Fibula Implant?

The FDA product code for Medline UNITE IM Fibula Implant is HWC. This falls under the Cardiovascular category.

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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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