FDA 510(k) Clearance
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Regulatory
X-Bolt Orthopedics Announces FDA 510(k) Clearance for Pro-X1™ Trochanteric Nail
DUBLIN, March 7, 2023 /PRNewswire/ — X-Bolt, an emerging innovator of orthopedic devices, is pleased to announce that its hip fracture solution,…
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Extremities
PeekMed® Unveils New Automated Orthopedic Solution for the US
BRAGA, Portugal, Feb. 21, 2023 /PRNewswire/ — PeekMed® sets new expectations for the orthopedic technology market with the launch of a web-based automated planning…
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Spine
Expanding Innovations, Inc. Announces FDA Approval of X-PAC Expandable Lateral Cage System
MOUNTAIN VIEW, Calif., Feb. 21, 2023 /PRNewswire/ — Expanding Innovations, Inc. (EI), a spinal implant company that designs NON-SCREW based expandable cage technology, announced…
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Spine
NuVasive Enhances C360 Portfolio with Expanded Indications for Modulus Cervical and Attrax Putty
Attrax Putty is now on-label for use with cervical Modulus interbody implants SAN DIEGO, Feb. 21, 2023 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the…
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Regulatory
Stryker’s Q Guidance System for cranial applications receives FDA clearance
Cranial Guidance Software offers surgeons robust imaging and guidance during cranial procedures February 17, 2023 KALAMAZOO, Mich.–(BUSINESS WIRE)–Stryker (NYSE:SYK), one…
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Spine
Curiteva Inc. Announces FDA 510(k) Clearance for Inspire 3D Porous PEEK HAFUSE Cervical Interbody System
Huntsville, AL based technology company, Curiteva announces the first FDA 510(k) cleared 3D printed PEEK implant, the Inspire Porous PEEK…
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Recon
Catalyst Receives FDA 510(k) Clearance for its Convertible Stemmed Total Shoulder Arthroplasty System
Catalyst is first-to-market with a fully convertible system that features an ellipsoid anatomic head February 9, 2023 NAPLES, Fla.–(BUSINESS WIRE)–Catalyst OrthoScience…
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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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