Breakthrough Device Designation
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Regulatory
FDA Grants Breakthrough Device Designation to ORTHOSON’s Bio-Structural Gel
This designation assures enhanced FDA cooperation and priority regulatory review of the company’s novel medical solution for back pain due…
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Regulatory
ZKR Orthopedics announces FDA Breakthrough Device designation for the LIFT Implant Technology
KENTFIELD, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) — ZKR Orthopedics, Inc., a clinical stage medical device company, today announced that…
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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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Recon
Exactech Announces FDA Breakthrough Device Designation for JointMedica’s Polymotion® Hip Resurfacing System
May 17, 2022 GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement…
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