FDA 510(k) Clearance
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Spine
Bone Solutions Inc. Receives FDA Clearance for Mg OSTEOREVIVE Spine Magnesium-Based Bone Void Filler
Colleyville, TX (February 2, 2022) / OrthoSpineNews / — Bone Solutions Inc. (BSI), a orthobiologics technology company located in Colleyville,…
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Spine
VySpine Announces FDA Clearance for ClariVy Cervical IBF System
Tallahassee, FL – February 1, 2021 / OrthoSpineNews / – VySpine, VySpine, a spine innovation leader using differentiated materials and…
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Regulatory
VUZE Medical Announces U.S. FDA 510(k) Clearance for Its VUZE System
Real-time Image Processing Enables Software-Only Guidance and Verification in Minimally Invasive Spine Surgery January 18, 2022 RA’ANANA, Israel–(BUSINESS WIRE)–VUZE Medical,…
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Financial
Surgalign Receives FDA Clearance for HOLO Portal™ System, the World’s First AI-driven AR Guidance System for Spine Surgery and Reports Preliminary Fourth Quarter and Full Year 2021 Results
Clearance is for use in the lumbar portion of the $5 billion instrumented fusion market* DEERFIELD, Ill., Jan. 18, 2022…
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Spine
VySpine Announces FDA Clearance of the VySpan PCT System
Tallahassee, FL – January 6, 2021 / OrthoSpine News / – VySpine, a spine innovation leader using differentiated materials and…
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Biologics
NuVasive Receives FDA Clearance for Expanded Indications of Use for Attrax Putty with Company’s Thoracolumbar Interbody Portfolio
Attrax Putty is the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems SAN…
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Regulatory
CoreLink Announces Commercial Launch Of CentraFix™ Midline Fixation System
CoreLink reveals the CentraFix Midline Fixation System, expanding their comprehensive Pedicle Screw System offering. The system features modular cobalt chrome…
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Extremities
Trice Medical breaks surgical boundaries with the world’s first FDA-cleared single-use 25° needle arthroscope – giving surgeons the tools they need to see more pathology
The Trice Medical 25-degree mi-eye 3 needlescope™ with one-of-a-kind horizon leveling technology has received FDA 510(k) Clearance, clearing the way…
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Regulatory
Life Spine Announces FDA 510(k) Clearance for the ProLift® Micro Expandable Spacer System
October 12, 2021 HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the…
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Regulatory
Intelivation Technologies received FDA approval for the Advantage-C™ PEEK Cervical Interbody Fusion device
–Saint Simons Island, GA, September 8, 2021 /OrthoSpineNews/: Intelivation Technologies, a medical device company with a growing product portfolio announced…
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Biologics
Royal Biologics announces FDA Approval of the Maxx™ Concentration System.
HACKENSACK, NJ, September 7th, 2021 /OrthoSpineNews/ – Royal Biologics, an ortho-biologics company focused on Autologous and Live Cellular solutions has announced FDA…
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Regulatory
MiRus Receives FDA 510(K) Clearance For The Lowest Profile and Best-in-class Expandable Lumbar Interbody
ATLANTA, Aug. 31, 2021 /PRNewswire/ — MiRus LLC, the leading innovator in rhenium-based superalloy medical implants announced today that it has received…
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Regulatory
Asensus Surgical Receives FDA 510(k) Clearance for Expansion of Machine Vision Capabilities
Additional Intelligent Surgical Unit™ (ISU™) features will further extend augmented intelligence leadership in surgery September 1, 2021 RESEARCH TRIANGLE PARK,…
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Extremities
Tyber Medical Receives Largest FDA 510(k) Clearance For Expanded Line Of Anatomical Plating Systems
BETHLEHEM, Pa., Sept. 1, 2021 /PRNewswire/ — Tyber Medical, LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma,…
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Regulatory
Intelivation Technologies received FDA approval for the Golden Isles Pedicle Screw System™
–Saint Simons Island, GA, September 1, 2021 /OrthoSpineNews/: Intelivation Technologies, a medical device company with a cutting-edge spinal implant product…
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