FDA-Device2019-12-11Class II
Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/- 20¿. The screws can be simply lagged or locked to the plate with the addition of a locking cap. The plates are side specific implants.
Miami Device Solutions, LLC.
Hazard
Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
Sold states
US Nationwide distribution in the states of FL, RI, MA, PA, NY, OH, GA, WA, AL, CA, TX, VA.
Affected count
15 units
Manufactured in
7620 Nw 25th St Ste 3, Miami, FL, United States
Products
Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/- 20¿. The screws can be simply lagged or locked to the plate with the addition of a locking cap. The plates are side specific implants.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0603-2020Don't want to check this manually?
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