fda clearance
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Regulatory
First Light Field-Enabled Spine Surgery Navigation Platform, Proprio Paradigm™, Receives FDA Clearance
Proprio’s Paradigm platform enables spine surgeons to operate more efficiently by providing fast registration and reducing the need for intraoperative…
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Spine
VySpine Announces FDA Clearance for UniVy OsteoVy-Ti Cervical IBF with NanoVy-HA
Tallahassee, FL — April 25, 2023 /OrthoSpineNews/ — VySpine, a spine innovation leader using differentiated materials and designs, announced today…
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Biologics
Abyrx Receives Additional FDA Clearances for MONTAGE® Settable, Resorbable Bone Putty as Bone Void Filler and Cranial Bone Cement
STAMFORD, Conn., April 5, 2023 /PRNewswire/ — Abyrx, Inc. (http://abyrx.com), a leading biomaterial sciences company with a focus on therapeutic technologies for…
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Spine
Spinal Resources Inc. Unveils Groundbreaking Spine Platform for Improved Patient Care
FDA-cleared Bezier Rod platform provides an unparalleled solution to address critical spinal conditions and improve patient outcomes. FORT LAUDERDALE, FL.,…
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Sports Medicine
FDA Provides Clearance of First-Ever Device for ACL Reconstruction in Children
Designed to address an “epidemic” of knee injuries in younger skeletally immature athletes, the device was developed and adapted for…
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Regulatory
SI-BONE, Inc. Announces FDA Clearance for Expanded Rod Compatibility with the iFuse Bedrock Granite® Implant System
New Indications Include Use with a Broad Class of Commercially Available Rods SANTA CLARA, Calif., Dec. 27, 2022 (GLOBE NEWSWIRE)…
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Spine
Providence Medical Technology announces FDA Clearance of the CAVUX® Facet Fixation System for the treatment of Cervical Pseudarthrosis
First integrated facet screw and cage system cleared by the FDA to revise a failed ACDF. PLEASANTON, Calif., Dec. 15, 2022 /PRNewswire/…
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Spine
VYRSA Technologies Announces Worldwide Launch of the VYRSA V1™ SI Fusion System
Integrated SI Fusion Device Receives FDA Clearance KING OF PRUSSIA, Pa., Dec. 2, 2022 /PRNewswire/ — VYRSA Technologies, a specialty medical device…
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Extremities
Enovis Receives FDA Approval of Patient Specific Instrumentation for STAR® Ankle
Wilmington, DE, Dec. 01, 2022 (GLOBE NEWSWIRE) — Enovis Corporation (NYSE: ENOV), an innovation-driven medical technology company, announced that the U.S. Food and Drug Administration…
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Spine
Stryker Launches Q Guidance System with Spine Guidance Software
First spine navigation software to receive clearance from the FDA for use with pediatric patients aged 13 and older KALAMAZOO,…
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Regulatory
Aurora Spine Announces New FDA indication clearance of Lumbar Spinal Stenosis for its ZIP™ series of MIS implants
CARLSBAD, Calif., July 12, 2022 (GLOBE NEWSWIRE) — Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF),…
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Top Stories
Xenco Medical Expands its Ambulatory Surgery Center Device Portfolio with FDA Clearance and Launch of its Multilevel CerviKit
Xenco Medical has expanded its ASC surgical device portfolio with the launch of its Multilevel CerviKit. SAN DIEGO – June…
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Spine
SI-BONE, Inc. Announces FDA Clearance for Expanded Indication of the iFuse-TORQ® Implant System
SANTA CLARA, Calif., June 13, 2022 (GLOBE NEWSWIRE) — SI-BONE, Inc. (SIBN), (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated…
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Extremities
Medline UNITE launches Calcaneal Fracture Plating System and IM Fibula Implant
Latest FDA cleared products to round out UNITE hindfoot and ankle trauma portfolio Northfield, Ill., April 25, 2022 /OrthoSpineNews/ –…
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Spine
Nexxt Spine Receives FDA Clearance on Navigation Compatible Instrumentation System
Noblesville, IN., April 21, 2022 /OrthoSpineNews/ – Nexxt Spine, LLC a leader in design and development of 3D printed, porous,…
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