510k
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K2M receives FDA 510(k) clearance for the next generation of its innovative complex spine MESA(R) technology
K2M Group Holdings, Inc., a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine…
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Hospitals
VEXIM to Initiate Clinical Study to Support Planned 510(k) Application to Market SpineJack® in the United States
VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM / Eligible PEA-PME), a medical device company specializing in the minimally invasive treatment of vertebral…
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Hospitals
52 spine, orthopedic devices receive FDA 510(k) clearance in July
Written by Laura Dyrda The Food and Drug Administration granted 52 orthopedic- and spine-related device exemptions in July. 1. Choice Spine Lumbar Spacer…
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Hospitals
Medtech insiders respond to FDA’s 510(k) split-predicate ban
August 6, 2014 by Arezu Sarvestani The FDA’s new guidance against split predicates in medtech 510(k) applications gets a largely warm welcome…
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Hospitals
FDA Often Sees No Data, Speaks No Data, Hears No Data—A Failure to Review Data in a 510(k)
Is FDA not reviewing your data in a 510(k) submission? Have you ever received a Not Substantially Equivalent (NSE) letter…
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Hospitals
Final rule prohibits “split predicates” under 510(k) process
July 29, 2014 by Arezu Sarvestani Medical device regulators clamp down on the 510(k) review pathway, prohibited manufacturers from splitting their primary…
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Robotics
Blue Belt Technologies Receives 510(k) Clearance for Patellofemoral Joint Replacement Application
MINNEAPOLIS–(BUSINESS WIRE)–Blue Belt Technologies has received FDA clearance to market their latest surgical application for the Navio® Surgical System, patellofemoral…
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Hospitals
How To Transfer Medical Device 510(k) Ownership
How To Transfer Medical Device 510(k) Ownership JANUARY 8, 2014 / MEDICAL DEVICE BLOG Medical device manufacturers might be surprised to know that…
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Zimmer Scores 510(k) Nod for Device to Aid Surgeons With Reverse Anthroplasty Procedures
Zimmer Holdings, Inc. (ZMH) may have gone down swinging in its most recent courtroom drama with Stryker, but the orthopedics…
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The Impact of Business Strategy and the FDA on the Future of Spine Surgery
At the 11th Annual Spine, Orthopedic & Pain-Management Driven ASC Conference on June 14, Frank Phillips, MD, of Rush University Medical…
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Anulex Technologies, Inc. Announces FDA Clearance for Expanded Indications of fiXate™ Tissue Band
MINNETONKA, Minn., Apr 04, 2012 (BUSINESS WIRE) — Anulex Technologies, Inc., a privately held medical device manufacturer, announced today that…
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Spine
FDA Grants Eden Spine 510(K) Clearance for its New Vertebral Body Replacement.
Altamonte Springs, Florida – Eden Spine (www.EdenSpine.com) announced today that it has received FDA 510(k) clearance for its new generation corpectomy…
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Spine
NLT SPINE Receives 510(k) Clearance for Its Lumbar Interbody Fusion Device, PROW FUSION(TM)
KFAR SABA, Israel, Feb 01, 2012 (BUSINESS WIRE) — NLT SPINE, a developer of Minimally Invasive Spine Surgery (MISS) products,…
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Hospitals
DuVal and Associates – CLIENT ALERT 1/2012
In this CLIENT ALERT we offer you a four part series (contained in one document) covering our thoughts on…
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Hospitals
Clear as Mud: Obtaining & Marketing your 510(K) with Today’s FDA
Knowing how to get your application through FDA quickly can save millions of dollars in unnecessary investment burn. Mr. DuVal,…
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