de novo
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Spine
MCRA Partner Orthobond Granted De Novo for Innovative Pedicle Screw System with Ostaguard™ Coating
MCRA Responsible for Regulatory Strategy and Support for FDA Submission Process WASHINGTON, May 7, 2024 /PRNewswire/ — MCRA, the leading privately held…
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Recon
FDA Authorizes Marketing of New Implant to Repair a Torn ACL
SILVER SPRING, Md., Dec. 16, 2020 /PRNewswire/ — Today, the U.S. Food and Drug Administration granted marketing authorization—under the De Novo premarket review…
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Hospitals
SANUWAVE Health Submits de novo Petition for FDA Review and Classification of the dermaPACE System to Treat Diabetic Foot Ulcers
ALPHARETTA, Ga., Aug. 11, 2016 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCBB:SNWV) today announced that it has submitted to the…
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