Miami Device Solutions, LLC

• HRS — Orthopedic5 devices
• HWC — Orthopedic1 device

• Z-0603-2020 — 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.Class II·Terminated·2019-01-15

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K182810 — Distal Radius Plating SystemCode HRS·2018-12-10
• K172786 — MDS Plating SystemCode HRS·2017-12-08
• K162898 — Olecranon Plating SystemCode HRS·2017-03-17
• K162635 — Distal Radius Plating SystemCode HRS·2016-10-21
• K161292 — Distal Radius Plating SystemCode HRS·2016-08-15
• K161058 — Cannulated ScrewCode HWC·2016-07-29