5 orthopedic devices earning FDA approval

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Here are five orthopedic devices and technologies that have received FDA approval, as reported by Becker’s since April 24:

  1. Alafair Biosciences earned FDA 510(k) clearance for the VersaCoat tendon protector and VersaCoat nerve protector.
  2. Exactech’s Equinoxe scapula reconstruction system earned FDA 510(k) clearance.
  3. Stryker secured FDA clearance for its Incompass total ankle system to treat patients whose ankle joints have been damaged by severe rheumatoid, post-traumatic or degenerative arthritis.
  4. Hyalex Orthopaedics earned FDA investigational device exemption for its Freestyle knee implant, opening up the door for clinical trials.
  5. Orthopedic implant company BioPoly secured FDA approval for its new knee implant.

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

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