FDA
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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
Premia Spine TOPS™ System Achieves FDA Premarket Approval with Superiority-to-Fusion Label
Data reveals significant superiority of TOPS facet joint replacement system over TLIF fusion in treating degenerative spondylolisthesis with stenosis. NORWALK,…
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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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Spine
Premia Spine Completes FDA Site Inspections With No FDA Observations
FDA inspections part of approval process for TOPS facet joint replacement system for lumbar arthroplasty April 13, 2023 NORWALK, Conn.–(BUSINESS…
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Regulatory
FDA Authorizes Marketing of MISHA™ Knee System for People Suffering from Knee Osteoarthritis
Implantable shock absorber (ISA) relieves pain and improves function in people ineligible for, or unwilling to undergo, joint replacement MISHA…
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Extremities
Pacira Announces FDA Acceptance of sNDA for Exparel Nerve Blocks to Produce Regional Analgesia in Lower Extremity Procedures
TAMPA, Fla., March 29, 2023 (GLOBE NEWSWIRE) — Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to…
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Spine
Osseus Announces First Ever FDA Standalone Indication for Integrated ALIF with Alternative Fixation
DALLAS, TX, February 20, 2023 /OrthoSpineNews/ – Osseus, an innovative spinal solutions company, announces that the Pisces-SA has been granted…
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Regulatory
Empirical Spine Completes Full Premarket Approval (PMA) Submission to FDA for LimiFlex™ Dynamic Sagittal Tether™
LimiFlex™ DST™ Is Designed for a New Class of Lumbar Stabilization Surgery That Meets the Demands of Value-Based Care. SAN…
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Extremities
Bioretec updates estimate of U.S. registration of RemeOs™ screws and expects approval in April 2023
TAMPERE, Finland, Oct. 14, 2022 /PRNewswire/ — Bioretec Ltd, a pioneer in bioresorbable orthopedic implants, continues to discuss the company’s RemeOs™ trauma…
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Spine
AxioMed LLC Submits Final Module III to the FDA Becoming the First and Only Lumbar Viscoelastic Total Disc Replacement Company to Complete a USA IDE Clinical Trial
On August 8, 2022, AxioMed LLC submitted to the FDA all the required documents for Module III. This is the…
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Spine
FDA Accepts & Closes Empirical Spine’s LimiFlex™ PMA Module II As A Motion-Preserving Alternative To Lumbar Fusion
SAN CARLOS, Calif., July 13, 2022 /PRNewswire/ — Empirical Spine, Inc., a medical device company creating a new class of spinal implant…
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Spine
Centinel Spine® Receives FDA Approval for 3 Additional prodisc® Cervical Total Disc Replacement Devices
Centinel Spine now has four PMA approved cervical Total Disc Replacement (TDR) devices, offering the broadest spectrum of solutions to…
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Spine
3Spine, Inc. Announces IDE Approval
CHATTANOOGA, Tenn., June 22, 2022 /PRNewswire/ — 3Spine, Inc., a medical device company developing total joint replacement for the lumbar spine, today…
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Biologics
MCRA Assists BONESUPPORT AB with the First Ever Combination Product DeNovo Decision Granted by the U.S. FDA
CERAMENT G is the first combination product which has successfully navigated the DeNovo process.To date, MCRA has supported 5 of…
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