fda clearance
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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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Regulatory
OSSIO Achieves Third FDA Clearance in 4 Months for OSSIOfiber® Implants; Prepares to Expand Patient Access to Bio-Integrative Orthopedic Fixation Technology Portfolio in Q2/Q3
New Suture Anchors, Industry’s First U.S.-Cleared Non-Permanent Compression Staples and Additional Compression Screws to Join Previously Launched Products That Leave…
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Regulatory
Shoulder Innovations Announces FDA Clearance of New InSet™ Stemless Humeral Implant
GRAND RAPIDS, Mich., March 14th, 2022 / OrthoSpineNews / – Shoulder Innovations Inc., (SI), a leading innovator in the development…
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Spine
SurGenTec Launches ION Screw, Smallest Posterior Spinal Fixation Implant, to Market After Receiving FDA Clearance
BOCA RATON, Fla., March 2, 2022 / OrthoSpineNews / – SurGenTec®, a privately held spine and orthopedic technology company based…
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Regulatory
Gramercy Extremity Orthopedics Receives Clearance on Its Newest Plating Lines
The RFID leader in medical devices expands its product offering by announcing FDA clearance for two new plating lines. February…
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Biologics
Kuros Biosciences’s MagnetOs Granules Cleared by FDA for Expanded Spinal Indications
Rare clearance for bone graft for standalone use in spine based on human clinical dataClearance attained with evidence from Level…
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