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X-spine Systems Inc.

Bacterin to buy X-Spine, rebrand as Xtant Medical in $86m deal

July 28, 2015 By Brad Perriello

Bacterin (OTC:BONE) yesterday said it agreed to acquire spinal implant maker  X-Spine Systems in a cash-and-stock deal worth about $86 million, including the assumption of debt, and rebrand as Xtant Medical Holdings. Belgrade, Mont.-based Bacterin, which makes allograft products using its in-house tissue bank, said the deal includes $60 million in cash, about 4.24 million Bacterin shares and […]

Filed Under: Mergers & Acquisitions, Orthopedics Tagged With: Bacterin International Holdings Inc., X-spine Systems Inc., Xtant Medical

X-Spine wins FDA clearance for spinal fusion system

May 16, 2013 By Sony Salzman Leave a Comment

X-Spine

X-Spine Systems won an FDA nod for its Zygafix facet fusion system, which stabilizes the facet joint using a hollow titanium compression screw and internal bone graft. The device is approved for patients who have failed traditional non-surgical treatments.

The Miamisburg, Ohio-based company is touting the device as an improvement over the Fixcet, which uses a solid titanium compression screw.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Spine Tagged With: X-spine Systems Inc.

X-spine lands FDA nods for 2 spinal systems

November 5, 2012 By MassDevice staff Leave a Comment

X-spine logo

Spinal implants and surgical instrument developer X-spine touted 2 FDA nods for its new spinal systems, which the company plans to include in a launching spree that will take place over the next year.

The next-generation Fortex CoCr system, which features a new cobalt-chromium fixation rod, is designed for the fixation of the thoracic and lumbar spine, particularly in deformity procedures.

Filed Under: Food & Drug Administration (FDA), News Well, Spine Tagged With: X-spine Systems Inc.

BSX touts FDA nod for spinal cord lead | Regulatory Roundup

December 8, 2011 By MassDevice staff Leave a Comment

BSX

Boston Scientific Corp. (NYSE:BSX) landed FDA clearance for its Infinion 16 percutaneous lead, designed for use with the company’s Precision Plus spinal cord stimulator system to control chronic pain.

The Infinion 16 lead is the first 16-contact percutaneous lead on the global market, doubling the previous max of eight stimulating contacts, according to the Natick, Mass.-based med-tech titan.

Filed Under: Implants, News Well, Pain Management, Spine Tagged With: AirXpanders, Boston Scientific, Breast Cancer, OraSure Technologies Inc., Regulatory Roundup, X-spine Systems Inc.

Diabetes: FDA clears t:slim portable pump and iglucose management system | Regulatory Roundup

November 17, 2011 By MassDevice staff Leave a Comment

Tandem
PositiveID

Tandem Diabetes Care and PositiveID (OTC:PSID) landed FDA clearance for their t:slim portable insulin pump and iglucose diabetes management systems, respectively.

Filed Under: Digital Health, News Well Tagged With: Carestream Health Inc., PositiveID Corp., Regulatory Roundup, tandemdiabetes, Torax Medical Inc., X-spine Systems Inc.

St. Jude gets Japanese go-ahead for smallest ICD and CRT in the industry

June 21, 2011 By MassDevice staff Leave a Comment

UnifyCRT

St. Jude Medical (NYSE:STJ) announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare for its Fortify implantable cardioverter defibrillator and Unify cardiac resynchronization therapy defibrillator, and the company launched the products in the Japanese market.

A ICD is an device that treats abnormally fast heart rhythms, and a CRT-D resynchronizes beating in the heart’s lower chambers, which often beat out of sync in heart failure patients.

Filed Under: Implants, News Well Tagged With: INVO Bioscience, Konica Minolta Opto Inc., Penumbra Inc., stjudemedical, X-spine Systems Inc.

X-Spine wins U.S. regulatory clearance for spinal fusion system

November 30, 2010 By MedCity News Leave a Comment

MedCity News logo

Spinal implants and surgical instrument developer X-spine Systems Inc. received 510(k) clearance from the Food & Drug Administration to begin selling a spinal fusion system.

The Axle system is designed to provide spinal stability for lumbar fusion procedures, according to the company.

Filed Under: Business/Financial News, News Well, Orthopedics Tagged With: X-spine Systems Inc.

X-spine wins FDA nod for spinal screw system

May 24, 2010 By MedCity News Leave a Comment

MedCity News logo

By Mary Vanac

X-spine Systems Inc. received 510(k) clearance from the Food & Drug Administration to sell its Fixcet spinal facet screw system.

Fixcet is used to stabilize the spine during spinal fusion procedures, such as treatment of degenerative disk disease, the company said in a press release. Facets are the wing-like bones on the backside of spinal vertebrae.

Filed Under: Business/Financial News, Food & Drug Administration (FDA), News Well, Orthopedics Tagged With: Gift Bans, X-spine Systems Inc.

X-spine Systems licenses spinal cage from Gamma Spine

March 9, 2010 By MedCity News Leave a Comment

By Mary Vanac

X-spine Systems Inc., a maker of implants and instruments for spinal surgery, agreed to an exclusive license with Gamma Spine to develop and distribute the minimally invasive spinal fixation technology invented by a professor of orthopedic bioengineering at the University of Toledo.

Filed Under: Business/Financial News, News Well, Orthopedics, Spine Tagged With: Gamma Spine, X-spine Systems Inc.

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