510k
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DiFUSION Technologies Receives 510(k) Clearance of Xiphos™ Interbody Implants for Spinal Fusion
AUSTIN, Texas–(BUSINESS WIRE)–DiFUSION Technologies Inc., a medical device company focused on the development and commercialization of its proprietary CleanFUZE™ anti-microbial…
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Wenzel Spine Announces FDA 510K Clearance
Wenzel Spine Gains 510K clearance to market the VariLift® Stand-Alone Expandable Interbody Fusion System AUSTIN, TX September 29, 2010 –…
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K2M Receives 510(k) Clearance for its CHESAPEAKE Anterior-Lumbar Stabilization System
LEESBURG, Va.–(BUSINESS WIRE)–K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, today announced…
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Medyssey Spine Receives FDA 510(k) Clearance for Zenius(TM) Thoracolumbar Spinal System in Titanium Alloy (Ti6AL-4V ELI)
LOS ANGELES, Aug. 25 /PRNewswire/ — South Korea-based Medyssey Co., Ltd. announced today that the Company has received 510(k) clearance from the U.S.…
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NuOrtho Surgical Receives FDA 510(k) Clearance
Fall River, MA, July 6, 2010, NuOrtho Surgical, Inc., a developer of leading edge surgical instruments, received 510(k) clearance from…
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Predictability Competes with Confidence in 510(k) Revamp
FDA’s massive revamp of its battered 510(k) market-entry program for medical devices has emerged as a struggle between two primary…
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Ulrich Medical Obtains 510(k) Approval
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090861.pdf
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Strategic orthopaedic-related 510(k)s issued in December 2009 include:
Pivotec Lumbar Interbody Fusion Device ( Captiva Spine) Align 360 Medialized Patella Component ( Cardo Medical) Anterior Cervical Plate (…
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NuOrtho Surgical secures $1 million in Series B Financing
Fall River, MA, November 17, 2009 — NuOrtho Surgical, Inc., a medical device firm focused on surgical instruments to enable…
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Custom Spine Announces 510k Clearance of Pathway AVID
PARSIPPANY, N.J., Oct. 22 /PRNewswire/ — Custom Spine, a pioneering leader in the development of spine treatment solutions, announced today…
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510(K) Approvals for September 2009
Atlas Spine: Atlas Spine Spacer Bacterin International: Osteoselect DBM Putty Blackstone Medical: Firebird Spinal Fixation System DePuy Spine: Modification to…
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