FDA 510(k) Clearance
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Spine
Alevio Spine Announces 510(k) Clearance of Expanded Indications for the SI-Cure SI Joint Fusion System
Birmingham, AL, January 31, 2023 /OrthoSpineNews/ – Alevio® Spine, a leader in the treatment of sacropelvic conditions, today announced 510(K)…
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Spine
icotec ag Receives FDA Clearance for the Ø 4.5mm VADER® Pedicle Screws
ALTSTAETTEN, Switzerland, Jan. 24, 2023 /PRNewswire/ — icotec ag, the leading medical device manufacturer of Carbon/PEEK spinal implants, announces the U.S. Food and…
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Regulatory
Conventus Flower Orthopedics Announces Expansion of its Flex-Thread™ Technology Platform with FDA Clearance of the Ulna Intramedullary Nail System
Flex-Thread™ Ulna Intramedullary Nail System HORSHAM, Pa., Jan. 19, 2023 /PRNewswire/ — Conventus Flower Orthopedics, an innovation-driven medical technology company, announced they…
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Spine
VySpine Announces FDA Clearance for LumiVy Lumbar IBF with NanoVy Ti
Tallahassee, FL – January 17, 2023 /OrthoSpineNews/—VySpine, a spine innovation leader using differentiated materials and designs, announced today that it…
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Regulatory
NanoHive Medical, LLC Receives FDA 510(k) Clearance for Hive™ Standalone Cervical System
NanoHive’s New Hive Zero Profile Standalone Cervical Cage Boston, MA, January 9, 2023 /OrthoSpineNews/ – NanoHive Medical has received 510(k)…
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Regulatory
Pristine Surgical Receives FDA 510(k) Clearance for Summit™, the World’s First 4K Single-Use Surgical Arthroscope
Designed to Improve Procedure Efficiency, Consistency, and Safety January 5, 2023 MANCHESTER, N.H.–(BUSINESS WIRE)–Medical device company Pristine Surgical received 510(k) clearance from…
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Regulatory
Episurf Medical receives FDA 510(k) clearance for Episealer® Patellofemoral System
December 27, 2022- Episurf Medical (NASDAQ: EPIS B) today announces that the company has received 510(k) clearance from the US…
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Spine
SURGLASSES received FDA 510(k) Clearance for Caduceus S
TAICHUNG, Taiwan, Dec. 19, 2022 /PRNewswire/ — SURGLASSES announced today that Caduceus S AR Spine Navigation System has received 510(k) clearance from the U.S.…
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Spine
Life Spine Announces FDA 510(K) Clearance for the TruLift® Lateral Expandable Spacer System and Lateral Plate System
HUNTLEY, Ill., December 14, 2022 –(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for…
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Spine
Eminent Spine’s ALIF Stand-Alone System Receives FDA 510(K) Clearance in October 2022
Eminent Spine’s ALIF Stand-Alone System includes PEEK and 3D Printed Titanium footprints. The implants are offered as non-sterile. Plano, TX,…
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Recon
Zimmer Biomet Expands Persona® Knee System Portfolio with FDA Clearance of Persona® OsseoTi® Keel Tibia for Cementless Knee Replacement
New Porous Iteration of Anatomic Keeled Tibia Designed to Deliver Stable Initial and Biological Fixation Together with the Clinically Proven Benefits of…
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Extremities
FDA Clearance Awarded to Tyber Medical for NiTy+ One-Shot Staple Fixation System
Innovative Bone Fixation System Offers Surgeons a Single-Step Staple Implantation Process BETHLEHEM, Pa., Nov. 15, 2022 /PRNewswire/ — Tyber Medical LLC, the…
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Recon
Exactech Announces FDA 510(k) Clearance of the TriVerse™ Primary Knee Replacement System
November 4, 2022 GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement…
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Robotics
Accelus Announces FDA 510(k) Clearance for Remi Robotic Navigation System Software Update that Allows Image Acquisition with all Major 3D Imaging Systems
PALM BEACH GARDENS, Fla., Nov. 03, 2022 (GLOBE NEWSWIRE) — Accelus, a privately held medical technology company focused on accelerating…
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Regulatory
CurvaFix Receives FDA Clearance for Smaller-diameter, Intramedullary Implant for Pelvic Fracture Fixation
November 1, 2022 BELLEVUE, Wash.–(BUSINESS WIRE)–CurvaFix, Inc., a developer of medical devices to repair fractures in curved bones, today announced…
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