designation
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Regulatory
FDA Grants Second Breakthrough Device Designation for Carlsmed Technology
CARLSBAD, Calif., September 20, 2023 — (BUSINESS WIRE)– Carlsmed announced today that the FDA granted Breakthrough Device designation for its…
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Regulatory
DirectSync Surgical receives Breakthrough Device Designation from FDA for its Patient-Powered Smart Implants
LAWRENCE, Kan., May 02, 2023 (GLOBE NEWSWIRE) — DirectSync Surgical, a medical device company dedicated to improving the lives of patients…
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Regulatory
Cresco Spine Receives FDA Breakthrough Status for SDS™ in the treatment of early onset scoliosis
May 2, 2023 – Schiedam, the Netherlands /OrthoSpineNews/ – Cresco Spine, a new player in the field of surgical treatments…
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Hospitals
Methodist Hospital for Surgery Receives Orthopaedic Center of Excellence Designation from DNV
ADDISON, TEXAS – October 18, 2022 /OrthoSpineNews/ — Methodist Hospital for Surgery has received the Orthopaedic Center of Excellence designation…
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Recon
Bozeman Health First in Montana to Achieve Orthopaedic Center of Excellence Designation from DNV
Bozeman, Montana, June 21, 2022 (GLOBE NEWSWIRE) — The Spine + Joint Institute at Bozeman Health has become the first…
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Regulatory
FDA Grants Theradaptive Breakthrough Medical Device Designation
FREDERICK, Md., Nov. 19, 2021 /PRNewswire/ — Theradaptive, a privately held biopharmaceutical company pioneering a new class of regenerative implants announced that…
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Hospitals
FLEXION THERAPEUTICS GRANTED FAST TRACK STATUS BY THE FDA FOR FX006 FOR TREATMENT OF OSTEOARTHRITIS OF THE KNEE
BURLINGTON, MASS., September 01, 2015 – Flexion Therapeutics, Inc. (Nasdaq: FLXN) today announced that the U.S. Food and Drug Administration (FDA)…
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