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Pre-Clinical Testing of Spinal Implants: Safety Versus Substantial Equivalence
Historically, the differences between the performance data threshold necessary to earn IDE approval versus the threshold to get 510(k) clearance has been very simple because most devices were clearly either class II or class III, where their design could clearly distinguish their intended use. However, a new trend is changing the landscape.

Company: MCRA
Type: White Paper
Date: February 01, 2008


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ProDisc-L Total Disc Replacement Surgical Technique
The ProDisc-L Total Disc Replacement is intended to replace a diseased and/or degenerated intervertebral disc of the lumbosacral region in patients with discogenic pain associated with degenerative disc disease (DDD) at one lumbar spinal segment level between L3 and S1.

Company: Synthes, Inc.
Type: Surgical Technique
Date: December 01, 2006


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Vitagel Preparation
Vitagel is an FDA approved surgical hemostat used to control bleeding and facilitate healing while utilizing the patient’s own biology. This video explains how to use it.

Company: Orthovita
Type: Video


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Medtronic Releases New Fixation System for the Spine
New System Gives Surgeons an Option When Treating Spinal Fractures and Tumors

Company: Medtronic, Inc.
Type: Press Release
Date: October 25, 2007


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Gary Carter receives a 3DKnee
In this video, baseball legend and Mets' Hall of Famer, Gary Carter, receives a 3DKnee™. Since this initial news report was broadcast, he is now back in the game managing the Mets' Gulf Coast League team.

Company: Encore Medical Corporation
Type: Video


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