FDA 510(k) K242373, Mako Shoulder Application (1.0)

Submitted by MAKO Surgical Corp., Weston Florida, received 9 August 2024 and cleared substantially equivalent on 7 November 2024. Regulation 21 CFR 882.4560, Class II, product code OLO. Indications cover surgical shoulder procedures including reverse shoulder arthroplasty.

Supporting location 510(k) clearance letter and Indications for Use

No current answer cites this record.