Breakthrough Device Designation
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Spine
SI-BONE Receives Transitional Pass-Through Payment Status for iFuse Bedrock Granite™
The iFuse Bedrock Granite™ system is a Breakthrough Device Designation technology that provides pelvic fixation and sacroiliac joint fusion, in…
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Spine
SI-BONE, Inc. Receives 510(k) Clearance and FDA Breakthrough Device Designation for Pelvic Fracture Fixation System
SANTA CLARA, Calif., Aug. 20, 2024 (GLOBE NEWSWIRE) — SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to…
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Spine
MiRus Receives Breakthrough Device Designation for Spine Implant
ATLANTA, July 31, 2024 /PRNewswire/ — MiRus has received Breakthrough Device Designation from the FDA for the EUROPA® Posterior Cervical System, based on it’s…
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Spine
Canary Medical’s Smart Spine Lumbar Cartridge Granted FDA “Breakthrough Device” Designation
Smart Spine Lumbar Cartridge is the fourth Canary Medical product to receive Breakthrough Designation through the FDA Breakthrough Devices Program…
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Regulatory
OrthoPediatrics Corp. Receives “Breakthrough Device” Designation from FDA for eLLi™ Growing Rod System for Pediatric Patients with Scoliosis
WARSAW, Ind., May 02, 2024 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of…
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Spine
Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ Spinal Interbody Cage
TAMPERE, Finland, March 14, 2024 /PRNewswire/ — Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has today been granted 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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Biologics
Biocomposites’ investee Renovos Biologics receives FDA Breakthrough Device Designation for its synthetic nanoclay bone fusion gel, RENOVITE® BMP-2
RENOVITE® BMP-2 is being developed as an alternative to bone graft materials for interbody spinal fusion It is the first product…
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Biologics
CGBio’s ‘NOVOSIS PUTTY’ Receives FDA ‘Breakthrough Device Designation,’ Accelerate Entry into the US Market
The first Korean developed medical device for spine implantation Expecte to receive faster approval in the U.S. by priority support…
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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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