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Monogram Technologies Says US FDA Grants 510(k) Clearance for Monogram mBos TKA System
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Monogram Technologies Says US FDA Grants 510(k) Clearance for Monogram mBos TKA System
Mar 17, 2025 5:43 AM

08:16 AM EDT, 03/17/2025 (MT Newswires) -- Monogram Technologies ( MGRM ) said Monday that its robotic-assisted total knee arthroplasty system, the Monogram mBos TKA System, has received a 510(k) clearance from the US Food and Drug Administration.

Monogram Technologies ( MGRM ) said the approval allows to market the device, subject to the requirements of the Federal Food, Drug, and Cosmetic Act.

The company said it is currently preparing for commercialization and reviewing strategies to support the adoption of that technology.

Shares of the company were up nearly 10% in recent Monday premarket activity.

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