FDA
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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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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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Spine
Spine BioPharma Initiating U.S. Phase 3 Clinical Study
SB-01 For Injection Offers New Potential Treatment for Patients Sufferingfrom Chronic Low Back Pain. New York, NY., May 11, 2022…
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Regulatory
FDA Grants PMA for the AccelStim Bone Growth Stimulation Device — Expanding Orthofix’s Portfolio of Market-Leading Bone Healing Therapy Solutions
May 4, 2022 LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus,…
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Regulatory
AxioMed Announces Progress with Completing Module I-III Lumbar FDA Submission of The First Lumbar Viscoelastic Disc Replacement to Complete a US IDE Clinical Study
AxioMed presses forward on its FDA submission of documents needed to complete the last Module III of its FDA application…
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Regulatory
FDA approves CartiHeal’s Implant for the Treatment of Cartilage and Osteochondral Defects
Approval is based on results of a multicenter, randomized, open-labeled and controlled IDE clinical study that demonstrated the superiority of…
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Biologics
Cerapedics Completes Enrollment of Pivotal U.S. FDA IDE Study for its P-15L Bone Graft
The ASPIRE study is intended to evaluate the use of P-15L Bone Graft in transforaminal lumbar interbody fusion surgery in…
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Spine
AxioMed LLC Files PMA Module II of III targeting 2022 FDA Approval of The First and Only Viscoelastic Lumbar Disc Replacement to Complete an IDE Clinical Study
AxioMed takes another historic step towards achieving FDA approval of its lumbar viscoelastic total disc replacement after submitting PMA Module…
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